At Celegence, you have the opportunity to shine and truly make a difference.

We have a growing organization where your inputs will be valued.

We have roles for all levels; both recent graduates and experienced professionals. We are currently looking for applicants with the following backgrounds.

Celegence offers competitive compensation and benefits, growth opportunities, and a supportive work environment.

Project Delivery Management - Celegence Life Sciences

Project Delivery Management

MDR Regulatory and Consultancy - Celegence Life Sciences

Regulatory Affairs Data Management

Compliance Data Management - Celegence Life Sciences

Compliance Data Management

Regulatory Intelligence - Celegence Life Sciences Regulations

Regulatory Intelligence

Why Celegence?

Join us and be a part of a remarkable journey!

Here at Celegence, you get a great team that always stands by you, a supportive Manager who makes sure you are absolutely comfortable with the work you’re doing, an amazing HR team who is always working up different ways to keep the employees motivated (also by sending lovely goodies every now and then), and most importantly, here you get the best leadership team that is equally concerned about employee’s career growth as they are about the development of this organization.

Employee Testimonials

Sowmya Raju - Celegence - Testimonial

Celegence is one of the most promising young companies in the industry. After more than two years working here, I can confidently say that it provides great opportunities to anyone in the organization looking to enhance their knowledge and skills. The culture has allowed me to grow my leadership and management skills, and it has also been motivating to have been part of the company’s growth since early on. Working at Celegence, a ‘typical day’ is never typical, there is always an interesting new challenge to navigate and every day is filled with learning opportunities. The company allows us to wear many hats, which keeps the workplace exciting and fast paced.

The aspect of Celegence that I have enjoyed most is the support system from Senior Management. They are open to new ideas and they always provide assistance for any obstacles that my team might be facing. I thoroughly enjoy working in such a collaborative atmosphere and am truly grateful to be a part of this organization.

Sowmya Raju, Senior Regulatory SME
Jegathis Kumar - Celegence Life Sciences
I am happy to be a part of the Celegence family. It has been a great learning experience from Celegence so far and the friendly environment here helps me work enthusiastically every single day. Because of the teamwork and the support from the team members I was able to achieve “The Employee of Choice Award” in a short period of time. Definitely looking forward to learning more and growing along with Celegence’s family.

Jegathis Kumar, Junior Associate, Regulatory Affairs
Koushik Chakraborty - Junior Associate Regulatory Affairs – Celegence

I started my professional career with Celegence. Right from the day of virtual on-boarding as a fresher in pandemic, till date, I feel Celegence is my [extended] family. With a positive work culture, teamwork, transparency, colleague support, and motivation from my seniors, I tend to grow each day. We celebrate each festival together. With work, we also focus on fun activities that relax us from our daily schedule. Celegence is growing every single day and so am I with Celegence. I recommend joining Celegence for people who really want to follow their passion and to get an amazing work experience. Thankful and obliged to Celegence for providing me with an excellent opportunity to excel in my career.This is my journey with Celegence!
What’s yours?

Koushik Chakraborty, Junior Associate, Regulatory Affairs
Koushik Chakraborty - Junior Associate Regulatory Affairs – Celegence

I have been working at Celegence for over a year. I have had the opportunity to work on challenging and complex projects in varied therapeutic areas that have further improved my skills as a medical writer. I am grateful to be working with a talented, diverse and supportive team that I can count on. I like that Celegence recognizes and appreciates the work and contribution the employees make towards the team and the organization. I am proud to be a part of Celegence that is making an impact in the healthcare sector via regulatory compliance.

Dr. Anushree Singh, Medical Writer
Akanksha Dhasmana - Instructional Designer - Celegence

I’m glad to gain experience in Celegence. This company allows you to wear multiple hats, empowers you with freedom to make decisions and has a great mix of all age groups to collaborate and create an inspiring work environment. I have a lot to be thankful to my Manager as they are behind this great learning experience. Right from my interview with my Manager and then later with the HR, I knew that Celegence is going to have a great enhancement in my learning. Not only is it a blessing to work with the team members and managers here, but it also gives me challenges that help me to hone my work and efforts. Also, I’m grateful to all my colleagues here who contributed to my journey so far. I’m definitely keen to cover many more years of this amazing learning.

Akanksha Dhasmana, Instructional Designer
Akanksha Dhasmana - Instructional Designer - Celegence

Celegence is a great place to work. The culture is transparent, every employee, irrespective of their position is given a chance to be heard, and there are very good opportunities available to those who want to build a career here.
It is a young organization with an innovative and entrepreneurial approach that distinguishes it from its competitors. I have been with the organization for almost 3 years now and have seen myself transform as a professional in more than one way. In the meantime, I have gained valuable experience on most of the interesting digital marketing activities to which I have been assigned. I have the utmost respect for the company’s drive to continuously develop new technologies and improve working process and employee skills. I work very closely with our COO which has given me a valuable insight into a different culture and great level of learning.

Santhosh Kumar, Senior Digital Marketing Analyst

Current Job Openings at Celegence

Senior Medical Writer – Romania

Employment Type: Full Time

Celegence is looking for a Senior Medical Writer in Romania with 3-6 years of work experience in Medical Device Regulatory Documentation, CER, CEP, PMSR and PSUR.

About the Company

Celegence LLC is a privately owned business based in Chicago, IL with offices in the U.K. and Bangalore. Celegence provides clients with consulting, services, and solutions to support their regulatory affairs operations and strategy. We support companies in ensuring regulatory compliance across the globe by providing both a platform and fully trained resources who understand the regulations and can leverage this knowledge to assist our clients in their day to day operations. We are currently building innovative technology to help our customers achieve efficiencies around global Regulatory compliance.

Celegence strives to be the premier niche provider of Regulatory Affairs services and technology in order to improve outcomes for the life sciences industry. Our primary objective is to provide end to end regulatory solutions that enable life science organization to deliver exceptional patient value.

Roles & Responsibilities

  • Ensure on-time development and delivery of various sections of high-quality regulatory documents compliant with MEDDEV 2.7/1 Rev. 4. and MDR for Medical Devices across therapeutic areas
  • Actively engage with internal stakeholders and cross-functional client business teams such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs
  • Deliver solutions that are customized per client requirements in terms of language, content, format, and presentation
  • Assist the Team Lead/Manager in the development of schedules to ensure timely delivery
  • Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables
  • Train and mentor junior members of the team on technical/process related aspects
  • Conduct proofreading, editing, document formatting, review comment incorporation and document completion / approval activities
  • Perform literature searches on various databases
  • Screening, appraisal per pre-defined criteria, and summarization of articles
  • Interpret and present data from device-specific technical documents such as User Manuals/Instructions for Use
  • Summarize quantitative data from post-marketing surveillance
  • Conduct editing, proofreading, document formatting, and other document completion/approval activities

Education & Experience

Education:

  • Bachelor’s Degree / Post Graduation in any relevant Life Sciences field. Master’s Degree is preferred

Experience:

  • Publication experience in scientific journals preferable
  • Minimum 3 years of experience in Medical Device Regulatory documentation
  • Familiarity with the Life Sciences Industry, preferably Regulatory Services
  • Hands on experience on CEP/CER/PMSR/PSUR process
  • Experience in creating high quality deliverables for customers
  • Experience in handling projects and engaging with multiple clients independently
  • Experience of working on projects involving all devices classes from various Therapeutic Areas

Skills

Technical Skills:

  • Knowledge of clinical evaluation and related documents and regulatory requirements
  • Proficiency in comprehension of scientific data and medical terminology and efficiency in summarizing information from source documents and published literature
  • Proficiency with Microsoft Office (Word, Excel, and Outlook)
  • Hands on experience on presentation tools such as PowerPoint, Visio etc., and referencing tools such as Zotero, Endnote, etc. will be an added advantage
  • Effective reviewing skills for review of work done by trainees/junior writers

Non-Technical Skills:

  • Strong verbal and written communications skills
  • Ability to work as part of a team
  • A constant zeal towards learning and skill development
  • Potential to multitask and work within timelines
  • Ability to understand and deliver on customer requirements
  • Mentoring skills to act as trainer/mentor for junior members of the team

Competencies:

  • Basic English grammar, punctuation, and sentence construction
  • Logical comprehension
  • Knowledge of medical terminology
  • Excellent Communication (Writing and Verbal)
  • Quality focused mindset
  • Good time management
  • Good stakeholder management

Personal Traits:

  • Positive Attitude
  • Initiative and Commitment
  • Detail Oriented
  • Team player
  • Focused and sincere
  • Ownership and accountability of work

Medical Reviewer – Regulatory Affairs – Bengaluru, India

Employment Type: Part Time

Celegence is looking for a Medical Reviewer in Bengaluru, India location with 4-8 years of work experience in Pharmacovigilance (PV).

About the Company

Celegence LLC is a privately owned business based in Chicago, IL with offices in the U.K. and Bangalore. Celegence provides clients with consulting, services, and solutions to support their regulatory affairs operations and strategy. We support companies in ensuring regulatory compliance across the globe by providing both a platform and fully trained resources who understand the regulations and can leverage this knowledge to assist our clients in their day to day operations. We are currently building innovative technology to help our customers achieve efficiencies around global Regulatory compliance.

Celegence strives to be the premier niche provider of Regulatory Affairs services and technology in order to improve outcomes for the life sciences industry. Our primary objective is to provide end to end regulatory solutions that enable life science organization to deliver exceptional patient value.

Roles & Responsibilities

  • MedDRA search strategy inclusive of knowledge on SMQ
  • Signal detection activities including preparation of evaluation report
  • Evaluation of PRAC report and provide justification for inclusion and exclusion
  • Review of gap analysis and provide medical justification comments for inclusion or exclusion of deviation
  • Review ADR and identify Preferred Terms (PT) for line listings
  • Review of line listings cases
  • Literature review
  • Health Authority website check for safety changes
  • Preparation of medical justification document
  • Provides general regulatory guidance
  • Coordinate with external teams for language translations and include translated information in the relevant documents
  • Ability to interpret and communicate scientific or medical information in a clear and concise manner
  • Provides general regulatory guidance
  • Mentoring less senior team members
  • Contributing as part of the Medical review team to develop processes, training plans/modules and SOPs
  • Perform other duties as assigned
  • Maintaining knowledge of the current regulations and upcoming changes
  • Review and inputs to aggregate reports and risk management plans (RMP)

Education & Experience

Education:

  • MBBS/MD

Experience:

  • 6+ years of combined experience in pharmacovigilance (PV), clinical research, clinical data management and medical practice
  • Good knowledge of ICH GCP and other regulatory requirements that govern the Safety of Medicines in EU, US and the Emerging markets
  • Experienced in Aggregate Reporting (PSUR/PBRER), Literature Review and Signal Detection

Skills

Technical Skills:

  • Strong understanding of the use of medical terminology

Non-Technical Skills:

  • Fluent in written and verbal English
  • Proficient with computer skills, including MS Office applications

Competencies:

  • Knowledge of PV regulations
  • Ability to multitask under tight deadlines while providing attention to detail and high quality work in a dynamic environment
  • Scientific knowledge sufficient to understand all aspects of regulatory issues

Personal Traits:

  • Good planner
  • Well organized
  • Strong team player

Project Management Officer (PMO) – Bengaluru, India

Employment Type: Full Time

Celegence is looking for a Project Management Officer (PMO) in Bengaluru, India location with 10-12 years of work experience in project management support.

About the Company

Celegence LLC is a privately owned business based in Chicago, IL with offices in the U.K. and Bangalore. Celegence provides clients with consulting, services, and solutions to support their regulatory affairs operations and strategy. We support companies in ensuring regulatory compliance across the globe by providing both a platform and fully trained resources who understand the regulations and can leverage this knowledge to assist our clients in their day to day operations. We are currently building innovative technology to help our customers achieve efficiencies around global Regulatory compliance.

Celegence strives to be the premier niche provider of Regulatory Affairs services and technology in order to improve outcomes for the life sciences industry. Our primary objective is to provide end to end regulatory solutions that enable life science organization to deliver exceptional patient value.

Roles & Responsibilities

  • Collaborate with internal departments/leaders to collate project management-related data/metrics to provide appropriate reports to the executive team
  • Contribute significantly to the successful execution of the projects, efficient resource utilization, and support the business to achieve set objectives
  • Enhance/Establish project governance framework/structure along with PM processes and methodologies
  • Support, design, and track project/program/portfolio performance KPIs
  • Support resource forecasting and capacity planning
  • Provide management reports, i.e., Report generation following a predefined script and preparation of custom reports for Project needs. Ensures the Daily/Weekly/Monthly reports are shared on time internally or externally
    • Overall progress and health of the projects
    • Prepare Utilization report (internal)
    • Analyze productivity and the root cause of slippage
    • Project/Program risks and associated mitigation/contingency plans
  • Ensure Project status reports are shared both externally and internally with all stakeholders
  • Take the lead on creating reports for these meetings with support from leadership/sales
  • Schedule meetings with clients that are part of governance – monthly and quarterly
  • Project work plan management support; keeping track of plans, budget, and quality standards. Deliverables and dependencies
  • Project metrics reporting and project finance management
  • Facilitation of internal and external meetings
  • Review the collated data to drive inferences and trends to improve process performance
  • Customize reports as required by clients (Specifically for governance meetings)
  • Prepare and follow up on MOM deliverables
  • Organizing project resource management

Education & Experience

Education:

  • Bachelor’s Degree/Post Graduation. Master’s Degree is preferred

Experience:

  • 10-12 years of experience in project management support
  • PMP Certified
  • Strong Knowledge of Microsoft Office (Excel, PowerPoint, Word)
  • Understanding of Earned Value, including SPI and CPI calculation for projects
  • Knowledge of MS Project or other project management tool(s) is an advantage

Skills

  • Proven work experience as a Project Management Officer or similar role
  • Strong leadership skills
  • Good written and verbal communication skills
  • Strong attention to detail and technicalities
  • Excellent organizational and technical abilities
  • Good interpersonal and multi-tasking skills
  • Relevant training and/or certifications as a Project Management Officer

Program Manager – USA

Employment Type: Full Time

Celegence is looking for a Program Manager in USA location with overall 12 years of experience with minimum 5 years of experience in medical device regulatory documentation.

About the Company

Celegence LLC is a privately owned business based in Chicago, IL with offices in the U.K. and Bangalore. Celegence provides clients with consulting, services, and solutions to support their regulatory affairs operations and strategy. We support companies in ensuring regulatory compliance across the globe by providing both a platform and fully trained resources who understand the regulations and can leverage this knowledge to assist our clients in their day to day operations. We are currently building innovative technology to help our customers achieve efficiencies around global Regulatory compliance.

Celegence strives to be the premier niche provider of Regulatory Affairs services and technology in order to improve outcomes for the life sciences industry. Our primary objective is to provide end to end regulatory solutions that enable life science organization to deliver exceptional patient value.

Roles & Responsibilities

  • Ensure on-time development and delivery of various sections of high-quality regulatory documents EU MDR and FDA for Medical Devices across therapeutic areas
  • Actively engage with internal stakeholders and cross-functional client business teams such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs
  • Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables
  • Ensuring process compliance and developing schedules to meet delivery timelines
  • Define processes, SOPs, and training modules where required (Optional)
  • Estimate efforts and timelines for projects and prepare and submit projection/utilization/progress status reports
  • Deliver solutions that are customized per client requirements

Education & Experience

Education:

  • College Degree in Regulatory Affairs or Technical or any relevant Life Sciences fields. A Master’s Degree is preferred

Experience:

  • Minimum 5+ years of experience in Medical Device Regulatory documentation. The overall experience of 12+ Years
  • Familiarity with the Life Sciences Industry, preferably Regulatory Services
  • Has created high-quality deliverables for customers independently and as part of a team
  • Experience in handling projects and engaging with multiple clients independently
  • Experience in working on projects with medical devices of all classes and different Therapeutic Areas
  • Demonstrable experience in managing a team, resource planning and allocation, etc.
  • Work experience in Medical Device development
  • Thorough understanding of Design & Development, Risk Management documentation, Post-market surveillance
  • Good understanding of Medical Device Quality Management System

Skills

Technical Skills:

  • Experience in executing or managing the execution of quality remediation or regulatory compliance efforts in engineering and/or medical device manufacturing or regulatory field(s)
  • To handle elements of project management regarding database management, data compilation, reporting, IT engagement, and tracking functions concerning the deliverables or scope of a workflow
  • Experience working with cross functional team and to work closely with direction of SMEs, Engineers, Customer employees, or Customer management
  • Experienced with Stakeholder management, project governance, monitoring, chair steering committee meetings, etc.
  • Good knowledge of Medical Device regulations of EU, FDA, Canada, etc.

Non-Technical Skills:

  • Strong verbal and written communications skills
  • Ability to work as part of a team and drive execution excellence
  • A constant zeal toward learning and skill development
  • Potential to multitask and work within timelines
  • Ability to understand and deliver on customer requirements
  • Strong leadership skills to guide and motivate the team
  • Decision-making skills with an innovative mindset
  • Presenting technical and project management-related artifacts

Competencies:

  • Keep up-to-date on the regulations
  • Excellent Communication (Writing and Verbal)
  • Continual process improvements
  • Quality focused mindset
  • Leadership and influence
  • Good time management
  • Good stakeholder management
  • Listening skills and patience

Personal Traits:

  • Positive Attitude
  • Initiative and Commitment
  • Detail Oriented
  • Team player
  • Focused and sincere
  • Ownership and accountability of work
  • Patient and a good listener
  • Interesting in learning and knowledge-sharing

Delivery Head – Cluj, Romania

Employment Type: Full Time

Celegence is looking for a Delivery Head in Cluj, Romania location with overall 15 years of delivery management, program management and advisory consulting experience.

About the Company

Celegence LLC is a privately owned business based in Chicago, IL with offices in the U.K. and Bangalore. Celegence provides clients with consulting, services, and solutions to support their regulatory affairs operations and strategy. We support companies in ensuring regulatory compliance across the globe by providing both a platform and fully trained resources who understand the regulations and can leverage this knowledge to assist our clients in their day to day operations. We are currently building innovative technology to help our customers achieve efficiencies around global Regulatory compliance.

Celegence strives to be the premier niche provider of Regulatory Affairs services and technology in order to improve outcomes for the life sciences industry. Our primary objective is to provide end to end regulatory solutions that enable life science organization to deliver exceptional patient value.

Roles & Responsibilities

Delivery Management:

  • Review and improve current service delivery models – Business Process as a Service (BPaaS), Center of Excellence (CoE), Advisory Consulting, etc.
  • Efficiently execute Service Delivery Model; this should include but not be limited to the list below
    • Implement and practice the company values
    • Execute and govern the current and future projects for global customers
    • Setup and manage the services team that is to deliver the different services
    • Accountable for resource utilization, management, and competency development
    • Achieve the KPIs and SLA related to the projects and effectively implement change management related to projects
    • Ensure appropriate and adequate resource allocation and skills and that backup roles exist for project continuity
    • Responsible for ensuring compliance with customer processes and systems
    • Review deliverables regularly, ensure proper project execution, and minimize risk on the project
    • Act as guide, coach, and counselor for the team
    • Effectively execute processes related to Quality Management, Communication, Governance, and Training and Continuous skill set improvement plan, Resource management, Project Management, Data Security, and Protection
    • Assist and support internal and external audits
  • Conduct Business Reviews with internal and external stakeholders regularly – Monthly, Quarterly, and Yearly
  • Execute “College to Corporate” program every year working with the recruitment team
  • Work with the Quality and Training department on different process areas related to service delivery and implement new processes as needed
  • Work with the HR department on the related processes – Human Resource management, recruitment, annual appraisals, etc.
  • Collaborate with other departments like Product Engineering, Product Management, Business Unit, etc. to improve service offerings and overall customer satisfaction
  • Collaborate with finance and account department related to contracts, invoicing, project summary reports and monitor the financial KPIs related to services
  • Understand and will abide by ISMS policy and processes of the company
  • Meet and excel the customer and organization needs by working closely with the senior leadership team and achieve operational parameters
  • Support other departments and management teams to define processes and policies

Strategic Initiatives:

  • Provide thought leadership to support organization in development of new business strategies and work with the other colleagues to initiate and implement new initiatives
  • Define and execute pilot projects and meet the goals and objectives by working closely with the management team, customers, and other internal departments
  • Define new processes for service delivery, setting up SLA and KPI to meet the business goals
  • Effectively roll out the new service offerings to existing and new customers

Business Development:

  • Interact with customers and prospects to help promote our offerings
  • Support development of sales and marketing materials to promote our business offerings
  • Support roadshows and industry events like DIA etc.
  • Support sales and business development functions in terms of proposals, responses to RFIs, RFPs, RFQs, and pre-sales meetings

KPIs:

  • Service Delivery KPIs that are individual:
    • Revenue Recognition
    • Gross Margin
    • Customer Satisfaction – CSAT
    • Employee Satisfaction – ESAT
    • Quality
  • Service Delivery KPIs that are individual:
    • Sales booking
    • Marketing
    • Strategic Initiatives

Education & Experience

Education:

  • Engineering or any relevant Life Sciences field. Master’s Degree preferred
  • PMP, RAC, ITIL certification is a plus

Experience:

  • Total experience of 15+ years with a minimum 5 years of relevant experience
  • Familiar with the Life Sciences industry, preferably Regulatory
  • Experience in managing multiple customers across geographies
  • Outstanding communication skills, both oral and written, and both technical and non-technical skills.
  • Well-versed with quality management processes
  • Understanding of global regulations related to Pharmaceutical, Medical Devices, Biologics in the context of service offerings
  • Involved in setting up service delivery teams and managing the growth
  • Has strong experience in at least one functional area – like Publishing, Labeling, Product Life cycle Management (CMC, Submissions, Strategy, etc.)
  • Able to travel up to 30% of the time
  • Fluent in English

Skills

Technical Skills:

  • Delivery Management: Design and deliver solutions that meet the business needs and manage delivery through a well-defined organizational structure
  • Project / Program Management: Budgeting, Planning, Initiation and Execution, Monitoring and Completion and achieve the KPIs and SLA related to the projects
  • Stakeholder Communications: Clear internal and external communication. Advises team on operating procedures for functional effectiveness
  • Team Management: People Management, Competency Assessment, and Skill Development
  • Thought Leadership: Relationship building with an aptitude for collaborating with internal and external stakeholders to identify business needs and develop solutions

Non-Technical Skills:

  • Strategic and planning skills
  • Good knowledge of business strategy development and implementation techniques
  • Strong management skills
  • Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem-solving skills

Competencies:

  • Excellent Communication (Writing and Verbal)
  • Customer Focused
  • Organization Skills
  • Drive to deliver superior quality proposals
  • Strong Time management
  • Good Stakeholder management
  • Strong Project management and tracking

Personal Traits:

  • Positive Attitude
  • Leadership Skill
  • Initiative and Commitment
  • Detailed Oriented
  • Team player
  • Focused and sincere
  • Perseverance

Product Manager – Cluj, Romania

Employment Type: Full Time

Celegence is looking for a Product Manager in Cluj/Romania location with 10 years of business analysis and product management experience. Candidate should be able to coordinate between the client (business) team, developers, and testing team.

About the Company

Celegence LLC is a privately owned business based in Chicago, IL with offices in the U.K. and Bangalore. Celegence provides clients with consulting, services, and solutions to support their regulatory affairs operations and strategy. We support companies in ensuring regulatory compliance across the globe by providing both a platform and fully trained resources who understand the regulations and can leverage this knowledge to assist our clients in their day to day operations. We are currently building innovative technology to help our customers achieve efficiencies around global Regulatory compliance.

Celegence strives to be the premier niche provider of Regulatory Affairs services and technology in order to improve outcomes for the life sciences industry. Our primary objective is to provide end to end regulatory solutions that enable life science organization to deliver exceptional patient value.

About the Role

The Product Manager will be responsible for defining and prioritizing the work for our development team to ensure the most valuable and proper functionality of the product for the end client (the internal business team). He or she will ensure the product meets our company’s goals of increased efficiency, quality, and compliance for our internal business team comprised of medical writers. Excellent communication, organizational, and analytical skills are a must.

As the Product Manager, you will gather feature requests, schedule releases and coordinate sprints. You should be able to identify user needs, help the customer understand business value and work with cross-functional teams to manage product releases. You will ensure that the product is made as efficiently as possible and listen to the users of the product, finding out what new features they want before gathering and analysing their feedback. This helps the overall team make decisions about the future of the product – what will and won’t be possible, which features to prioritise or to drop altogether and produce product roadmaps. You will also be responsible for the life cycle of the product, ensuring that everyone is following the product roadmap and that features are being released on time and are of a high quality.

In your role, you may focus mostly on the users of your product, sometimes referred to as product marketing, or on the creation of the product itself, known as product development. Your effort is important for the company as you will need to deliver product not just according to users, but the product that helps make our company vision a reality.

Roles & Responsibilities

  • Serve as the voice of the client
  • Work with internal and external customers to analyze the needs and align product roadmap to strategic goals
  • Owns the product roadmap
  • Develop scope and define backlog items (epic/features/user stories) that guide the Agile software development team
  • Solve product related problems, make decisions, complete trade-off analysis to stay on track towards business deliverable commitments
  • Draft key objectives and results, strategies and apply the data for the product to make business decisions
  • Possess a fundamental understanding of end-to-end customer experience integration and dependencies
  • Collaborate with stakeholders during the visioning and concept development of a product
  • Accountable for the created product(s), delivering in the product model and communicating the product needs with business partners
  • Asses value, develop cases, and prioritize stories, epics and themes to ensure work focuses on those with a maximum value that are aligned with product strategy
  • Identifies and help the client understand the business model, value and value proposition
  • Develop and maintain an appropriately prioritized backlog of user stories for implementation
  • Act as an ambassador for the product internally and externally and as the primary contact for queries related to the product
  • Develop appropriately detailed specifications for the product features so they are clearly understood by the development teams
  • A leader of the team
  • Represents team in front of stakeholders, clients or users
  • A member of the team
  • Work closely with product management and senior management in order to create a product that fits the company portfolio
  • Research and analyze market, the users, and the roadmap for the product
  • Follow our competitors and the industry
  • Increase an understanding of Agile practices, Lean Startup, new technologies opportunities and other new trends

Experience

  • Excellent communication and analytical skills
  • Entrepreneurship skills or experience
  • Creative thinker
  • Strategic thinking
  • Product Management
  • Experience in sales or marketing is an advantage
  • Management of stakeholders and their expectation
  • Deep understanding and experience with Agile methodologies
  • Ability to work with cross-functional teams to deliver on a common goal
  • Interpersonal skills and developing relationships with team members and customers
  • Experience with a definition of minimum marketable features and minimum viable products
  • Knows how to define the product roadmap
  • Outstanding communication, presentation and leadership skills
  • Organizational and time management skills
  • Analytical and problem-solving skills
  • Attention to details
  • Discipline
  • Active listening
  • Overall understanding of technologies used in the product

Skills and Competencies

  • Knowledge (or ability to learn a new market) of industry trends
  • Ability to set and track key KPIs
  • Ability to analyze data and customer feedback to find product-market fit and prioritization of requirements
  • Strategic thinking to define a product roadmap
  • Basic understanding of UX design – very handy if you are able to put a prototype together
  • Basic technical understanding – knowing when to push back on a customer if something is not technically feasible
  • Excellent time-management and project management skills
  • Excellent communication skills and ability to represent the voice of the customer, synthesizing the voices of senior stakeholders
  • Ability to negotiate – find creative agreements between two or more parties (such as customer team and technical team, for example)
  • Ability to figure out how much a new idea is worth to the company by collecting information from multiple stakeholders

Senior Solutions Engineer – UK/Cluj/Romania

Employment Type: Full Time

Celegence is looking for a Senior Solutions Engineer in UK or Cluj or Romania location with 10 years of experience.

About the Company

Celegence LLC is a privately owned business based in Chicago, IL with offices in the U.K. and Bangalore. Celegence provides clients with consulting, services, and solutions to support their regulatory affairs operations and strategy. We support companies in ensuring regulatory compliance across the globe by providing both a platform and fully trained resources who understand the regulations and can leverage this knowledge to assist our clients in their day to day operations. We are currently building innovative technology to help our customers achieve efficiencies around global Regulatory compliance.

Celegence strives to be the premier niche provider of Regulatory Affairs services and technology in order to improve outcomes for the life sciences industry. Our primary objective is to provide end to end regulatory solutions that enable life science organization to deliver exceptional patient value.

Technical Skills

  • NodeJS
  • Express
  • MongoDB
  • ReactJS
  • Redis
  • AWS
  • MobX

Experience

  • 10+ years of experience

Competencies

  • Possess strong verbal and written communications skills
  • Ability to influence others & problem resolving skills
  • Ability to work independently
  • Should be a team player

HR Professional

Key Skills

  • Good knowledge of HR operations starting from onboarding till exit, good communication, teamwork etc.

Experience:

  • 7-9 years of relevant experience

Employment Type: Full Time

Work Location: Bengaluru

Recruiter

Key Skills

  • Strong communication, teamwork, strong networking and relationship-building skills etc.

Experience:

  • 7-9 years of relevant experience in life science/pharma company

Employment Type: Full Time

Work Location: Bengaluru

Quality and Training Professional

Key Skills

  • Knowledge of Quality Management System and Internal Audit Process (as per ISO standards) etc.

Experience:

  • Overall 4 years with 2+ years in quality system function

Employment Type: Full Time

Work Location: Bengaluru

In Vitro Diagnostic Device Consultant / Subject Matter Expert

Roles & Responsibilities

  • Ensure on-time development and delivery of high-quality regulatory documents (Technical files, GSPRs, Gap Assessments, Risk management documentation, etc.) compliant with IVDR
  • Ad-hoc support with marketing activities, such as webinars, blog writing, as well as business development activities such as presales meetings with prospective clients
  • Actively participate in client bid defense meetings for IVD / Medical Device prospective projects
  • Provide advisory consulting services, proactively monitor regulations across regions to advise companies on new regulations
  • Provide SME consulting in the areas of regulatory strategy, submissions, and operations
  • Support building (technical) documentation and design dossiers in support of CE marking, 510(k), or other approval procedures
  • Provide SME consulting for Regulatory compliance according to the current EU Directives (i.e. MDD & IVD), new EU Regulations MDR & IVDR (EU 2017/745 & EU 2017/746), FDA, ANVISA, Health Canada, MHLW/PMDA & TGA (MDSAP requirements)
  • Lead IVDR gap analysis projects and conduct an analysis of existing systems, processes, and departments in terms of new regulation:
    • Implement improvements to technical files and other documents like Performance Evaluation Plan, Performance Evaluation reports
    • Understand current compliance situation of the medical device for international standards
    • Suggest and support the implementation of changes to the organization’s risk management processes
    • Develop device risk assessments with input from clinical and technical experts within the organizations
    • Identify actions required to ensure compliance with ISO 13485, MDSAP and IVDR
    • Support and conduct updates to labelling, SOPs, work instructions, trending tools and policy documents to ensure compliance with EU-IVDR
    • Make updates to labelling, SOPs, work instructions, and policy documents to ensure compliance with the client’s corporate SOPs
  • Assist in the development/construction of Technical Files according to the new IVDR & STED format with emphasis on developing following documentations:
    • Essential Requirements Evaluation Report to Annex I of MDR & IVDR
    • Risk Management Reports / Documentation to ISO 14971:2012
    • Clinical Evaluation Report development according to MDR & IVDR and/or MEDDEV 2.7.1 Rev 4
    • PMPF Planning Report development according to IVDR and/or MEDDEV
    • Development of Vigilance Reporting strategies to IVDR and/or MEDDEV
  • Maintain, develop, and share your expertise and knowledge on a specific expert area and participate in IVDR related forums to understand the latest trends as well as approach prospective clients
  • Support regulatory submission projects with submission requirements for appropriate market and product type
  • Establish and maintain a professional and credible relationship with direct clients (customer of Celegence) and indirect clients like Health Authorities, Notified Bodies, and other regulatory agencies
  • Responsible for the operational planning of the project and prepares weekly plans for the team which are in line with the project timelines
  • In collaboration with Quality Assurance, ensure that project team members are appropriately trained on all project SOPs, guidelines, and documents as required
  • Proactively follow the news and trends in the market to share with the rest of the team
  • Supporting internal and external audits as required
  • Provide status reporting to stakeholders according to an agreed communications plan

Education & Experience

Education:

  • Bachelor’s Degree in pharmacy or Regulatory Affairs or any relevant Life Sciences fields. Master’s Degree is preferred
  • RAC certification: Medical Devices or In Vitro Diagnostics is a plus

Experience:

  • Minimum 5 years of working experience in the field of IVD/medical devices through positions in industry, consultancy, or regulatory agencies (Notified Bodies, FDA, EMA), in either manufacturing, R&D, quality, or regulatory roles
  • A proven track record for driving quality/compliance improvements across all levels and functions
  • Experience in IVDR remediation projects, writing IVDR compliant reports and documents
  • Knowledge of Quality Management System and ISO 13485
  • Regulatory Affairs compliance and QMS assessment of Technical Files
  • Knowledge of Risk Management Systems based on ISO 14971:2012
  • Experience in creating customer facing materials and conducting workshops as SME
  • Knowledge of Medical Device Regulations related to major health authorities of US, EU, Japan, China, Australia, Brazil, Canada

Skills and Competencies

Technical/Functional Skills:

  • Excellent knowledge of IVDD/IVDR
  • Excellent knowledge of ISO 13485 standards
  • Good understanding of IMDRF requirements for member countries
  • Strong stakeholder management experience

Non-Technical Skills:

  • Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem resolving skills
  • Good knowledge of strategy development and implementation techniques for Medical Device registrations, compliance towards new regulations, etc.
  • Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem resolving skills

Competencies:

  • Excellent Communication (Writing and Verbal)
  • Customer Focused
  • Organization Skills
  • Strong Time management
  • Good Stakeholder management
  • Project management and tracking

Personal Traits:

  • Positive Attitude
  • Initiative and Commitment
  • Leadership Skills
  • Detailed Oriented
  • Team player
  • Focused and sincere
  • Perseverance
  • Flexibility to work on other PMS documentation complying with the IVDR

Senior Regulatory Analyst

Roles & Responsibilities

  • Ensure on-time development and delivery of high-quality regulatory documents (Technical files, GSPRs, Gap Assessments, Risk management documentation, etc.) compliant with MDR and IVDR
  • Actively engage with internal stakeholders and cross-functional client business teams such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs
  • Deliver solutions that are customized per client requirements in terms of language, content, format, and presentation
  • Assist the Team Lead/Manager in the development of schedules to ensure timely delivery
  • Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables
  • Train and mentor junior members of the team on technical/process related aspects
  • Conduct proofreading, editing, document formatting, review comment incorporation, and document completion/approval activities
  • Interpret and present data from device-specific technical documents such as User Manuals/Instructions for Use
  • Conduct editing, proofreading, document formatting, and other document completion/approval activities

Education & Experience

Education:

  • Bachelor’s Degree or Postgraduate Degree in any relevant Life Sciences field. Master’s Degree is preferred.

Experience:

  • Thorough understanding of Gap assessment of Technical file, Gap assessments for PMS, QMS, Harmonized standards
  • Hands-on experience on Technical files, PMS, QMS, Harmonized standards document remediation
  • Preparing GSPR checklists
  • Sound understanding DHF Remediation, Risk Remediation, Design Controls, Design Risk Management (DFMEA), Design Inputs & Outputs, Design Verification & Validation, and Product Requirements
  • Minimum 3 years of experience in Medical Device Regulatory documentation
  • Familiarity with the Life Sciences Industry, preferably Regulatory Services
  • Experience in creating high-quality deliverables for customers
  • Experience in handling projects and engaging with multiple clients independently
  • Experience in working on projects involving all devices classes from various Therapeutic Areas

Skills and Competencies

Technical Skills:

  • Knowledge of Technical file remediation and related documents and regulatory requirements
  • Understanding of Medical Devices Directive (MDD) 93/42/EEC, Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC, (EU) 2017/745 (MDR), (EU) 2017/746 (IVDR)
  • Proficiency with Microsoft Office (Word, Excel, and Outlook)
  • Hands-on experience on presentation tools such as PowerPoint, Visio, etc., and referencing tools such as Zotero, Endnote, etc. will be an added advantage
  • Effective reviewing skills for review of work done by trainees/junior writers

Non-Technical Skills:

  • Strong verbal and written communications skills
  • Ability to work as part of a team
  • A constant zeal towards learning and skill development
  • Potential to multitask and work within timelines
  • Ability to understand and deliver on customer requirements
  • Mentoring skills to act as trainer/mentor for junior members of the team

Competencies:

  • Basic English grammar, punctuation, and sentence construction
  • Logical comprehension
  • Knowledge of medical terminology
  • Excellent Communication (Writing and Verbal)
  • Quality focused mindset
  • Good time management
  • Good stakeholder management

Personal Traits:

  • Positive Attitude
  • Initiative and Commitment
  • Detail Oriented
  • Team player
  • Focused and sincere
  • Ownership and accountability of work
  • Flexibility to work on other PMS documentation complying with the MDR and IVDR

Senior Medical Writer – CER

Employment Type : Open for full time/Remote based working/Contractual basis

Celegence is seeking a Senior Medical Writing Specialist to join our consulting team in support our expanding list of Medical Device clients. The medical writer will be responsible for preparation of documents that support the presentation and/or publication needs of assigned therapeutic areas and/or medical devices in the clients Strategic Medical Affairs Team for a wide range of audiences.

Roles & Responsibilities

  • Ensure on-time development and delivery of high-quality CERs compliant with MEDDEV 2.7/1 Rev. 4. And EU MDR for devices across therapeutic areas
  • Be adept at delivering solutions that are customized per the client requirements
  • Assist in the development of schedules to ensure client CER timelines are met
  • Perform literature searches, screen and summarize literature for relevant clinical evidence
  • Study device-specific client documents and report device characteristics and instructions for use
  • Summarize data from post-marketing surveillance and perform risk analysis for the devices in scope
  • Actively engage with cross-functional client business teams such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs relating to the CER process
  • Work with the team and Team Lead to prepare documents that meet client expectations in terms of content, format, and presentation
  • Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables
  • Conduct proofreading, editing, document formatting, review comment integration and document completion / approval activities

Education & Experience

Education:

  • Bachelor’s Degree / Post Graduation in any relevant Life Sciences fields. Master’s Degree is preferred
  • RAC certification is a plus

Experience:

  • Minimum 4 – 7 years of experience in Medical Device Regulatory documentation
  • Familiar with the Life Sciences Industry, preferably Regulatory Services
  • Hands on experience on CER to perform job
  • Experience in creating customer facing materials

Skills and Competencies

Technical / Functional Skills:

  • Experience within the medical device industry and knowledge of clinical evaluation report, regulatory requirements, evidence generation, and CER document creation
  • Experience in Literature Search, Review and Analysis, Risk Benefit Assessment, Equivalency Approach, Post Market Surveillance Data Analysis including Trend CER Analysis, Non-Clinical/Clinical Data (pre-clinical, Sponsored studies/IIR), State of the Art (SotA) and Conclusions
  • Experience in performing medical literature searches (PubMed, Google Scholar, etc.)
  • Hands on experience on presentation tools like PowerPoint, Visio etc. will be an added advantage

Non-Technical Skills:

  • Strong verbal and written communications skills
  • Ability to work independently
  • Fluent in English

Lead Biostatistician – India

Employment Type : Full time

Education & Experience

Education:

  • MA or MSc in statistics subject, preferably with a strong medical statistics component (Alternative academic qualifications are assessed for comparability)

Experience:

  • 3 to 5 years of postgraduate experience in the application of statistics in clinical studies with a MSc/PhD in statistics subject with competence in the preparation of Statistical Analysis Plans, analysis, reporting, etc., across a variety of clinical studies
  • A good knowledge of the overall Clinical study processes, regulatory requirements, and its application in Medical device or Pharma industry
  • SAS proficiency including use of a variety of statistical procedures, e.g., nonparametric analysis, linear and non-linear models, categorical data, and survival analysis
  • Experienced in using statistical tools such as SPSS, Matlab, Minitab, etc.
  • Interpersonal and effective communication skills, strategic thinking, and problem resolving skills
  • The ability to work in tight deadlines while maintaining high standards

Skills and Competencies

Technical / Functional Skills:

  • Provide statistical guidance in development of clinical research programs such as Post-market clinical follow up (PMCF) studies and responsible for statistical inputs in design of individual studies as part of multi-disciplinary team
  • SAS programming and related activities for the presentation and analysis of clinical trial data. Knowledge of R a plus point
  • Develop and coordinate QC procedures for Biostatistics deliverables, perform independent peer review of statistical deliverables, and follow audit procedures/protocols
  • Contribute to client meetings for biostatistical programming related activities
  • Adhere to appropriate SOPs within the framework of GCP and other quality management systems

Non-Technical Skills:

  • Strong verbal and written communications skills
  • Ability to work as part of a team and drive execution excellence
  • A constant zeal towards learning and skill development
  • Potential to multitask and work within timelines
  • Ability to understand and deliver on customer requirements
  • Mentoring skills to act as trainer/mentor for junior members of the team
  • Strong leadership skills to guide and motivate the team
  • Decision making skills with an innovative mindset

Senior SME – Medical Device Registration – India

Employment Type: Full time

Roles & Responsibilities

  • Overall Project management of the assigned Medical device registration
  • Responsible for development and management of the overall project plan
  • Single point of contact for any project related information for client and management team
  • Responsible for tracking and updating project status (weekly meeting, trackers, telecon) to external and internal stakeholders
  • Familiarize with pharmaceutical and medical device products related regulations, requirements and guidelines. Also, be responsible for the implementation and compliance of the regulatory requirements
  • Manage product registration in line with company strategy to ensure compliance with local regulatory requirement and company requirements
  • Ensuring ongoing compliance and maintenance of product registration to meet regulatory and business obligations.
  • Work closely with local regulatory authorities to ensure a high level of current knowledge is maintained regarding product registration and maintenance of product within the market segments the business aims to conduct its business
  • Ensuring promotion materials and communication to HCPs, customers and end users are reviewed in line with the company and industrial Codes of Conduct. Apply advertisement permit when required
  • Manage the reporting and management of Pharmacovigilance activities for Medical Devices in India, Sri Lanka and Bangladesh in accordance with the company SOPs and local regulatory requirements
  • Support local quality activities by working closely with cross functions and external organization like:
    • Local Commercial, Supply Chain team
    • Global RA, Packaging Group, Global Quality
    • Regional RA and Country RA teams
    • Consultants and Distributors
    • Government Agencies, Medical/Regulatory Authorities
  • Review and approve pharmaceutical product labels or artworks for production
  • Review and approve repack and relabel instruction for pharmaceutical products
  • Provide consultations to resolve the problems or incidences due to the regulations change
  • Develop regulatory affairs best practices, processes and procedures
  • Understands and will abide by ISMS policy and processes of the company

Education & Experience

Education:

  • Bachelor’s Degree in pharmacy or Regulatory Affairs or any relevant Life Sciences fields. Master’s Degree is preferred
  • RAC certification: Medical Devices is a plus

Experience:

  • 6-8 years related work experience in Pharmaceutical and Medical Device field
  • Familiar with the Life Sciences Industry, preferably Regulatory
  • Hands on experience in managing all regulatory affairs activities and ensuring full regulatory compliance for medical devices in India, Sri Lanka and Bangladesh is a must
  • Good understanding of device registrations in EU, US, Australia, and other major markets
  • Understanding of global regulations related Pharmaceutical, Medical Device, Biologics in the context of service offerings
  • Fluent in English

Labeling Subject Matter Expert – Regulatory Affairs

Roles & Responsibilities

  • Ensure setting up end to end processes for CCDS management related to Customer’s product lifecycle activities
  • Responsible as the Subject Matter Expert (SME) for project activities, coordination with offshore team and representatives from different departments at Customer, as well as hands-on document preparation using the relevant tool in coordination with the Project Manager
  • Perform label reviews
  • Undergo training by Customer for their specific processes (e.g.; SOP), systems for data extraction, quality review procedures etc. and train the rest of the team of Celegence
  • Understand report template requirements and existing reports for updates as part of the project activities
  • Understand various source documents and reports like company core data sheet, SmPC, US labels, HA assessment reports, previous finalised reports etc.
  • Provides guidance for literature search and literature review
  • Responsible for development and amendment of CCDS
  • To review the Clinical Overview, Non-Clinical Overview, medical evaluation document, and any safety-related documents required for the development of CCDS
  • Supports gap analysis activities, preparation of draft CCDS, Health authority website check and other activities which are performed as a part of CCDS creation and update
  • Provide consultative solutions related to labeling life cycle to Customer to help improve the overall process
  • Provides general regulatory guidance

Experience

  • Minimum 8-12 years of experience
  • End to end experience in labeling lifecycle management
  • Experience in Regulatory Affairs related to Labeling across major Markets (US, EU, UK, Japan, China, Australia) and ROW (Rest of the World)
  • Knowledge of RA regulations Hands on experience in Creation and maintenance of Company Core Data Sheets (CCDS), Summary of Product Characteristics (SmPC) and other types of labels
  • Scientific knowledge sufficient to understand all aspects of regulatory issues

SME – Regulatory Information Management System – Global

Celegence is looking for a Subject Matter Expert with at least 8 years of experience in Regulatory Information Management Systems (RIMS) business processes and standards.

Roles & Responsibilities

  • Responsible for providing SME consulting related to RA systems like Regulatory Information Management system (RIMS), Document or Content Management System and eCTD submissions
  • Lead training content development for RIMS solution overing various business process areas like Product portfolio management, Registration / License management, Change management, Compliance data management, CMC and Labeling related processes, Dossier management, Publishing and Submission management, business processes relate system integrations
  • Lead demo and business process walkthrough sessions to the end-users as well as super users of RIMS
  • Manage various activities in the RIMS database under product life cycle management (Registration, Variation, Renewals, and submission)
  • Define and ensure KPIs and SLAs related to regulatory business processes and deliverables
  • Adherence to appropriate regulatory guidelines, departmental SOPs and Client SOPs for the deliverables
  • Complete trainings provided by Client, and regular self-trainings; archive training certificates/records
  • Assist and support internal audits performed by the Client
  • Support implementation of Regulatory Affairs systems as per Client or Partner projects
  • Support peers and resolve issues related to the project
  • Develop and establish standard processes in collaboration with QA submission related checklists and template preparation(wherever applicable)
  • Conduct quality control of performed regulatory work as part of the daily routine
  • Set-up and maintain local SOP system describing all procedures and processes in order to ensure compliance and share with Client
  • Understands and will abide by the IQMS policy and processes of the company
  • Working knowledge of learning management systems
  • Take training and quality management ownership for the project

Education

  • Bachelor’s Degree in pharmacy or any relevant Life Sciences fields. Master’s Degree is preferred
  • RAC certification is a plus

Experience

  • Minimum 8 years of relevant Regulatory Affairs experience required
  • Hands-on experience for end-to-end Regulatory Operations for Mid/Large-sized Life Sciences companies
  • Experience with xEVMPD and IDMP will be preferred, including process definition and optimization for RIMS
  • Skilled in Regulatory Information Management
  • Business processes experience and a good understanding of RIMS processes, Publishing, Labeling, CMC and Other Variations, Manufacturing and supply chain, etc.
  • Performed SME role in the past for implementation projects and regulatory affairs related to business process areas and training delivery experience is a plus
  • Hands-on experience at developing eLearning courses with SCORM/AICC Compatible for LMS along with Instruction Design
  • Design and develop training courses and programs necessary to meet training needs, or manage this activity via internal /external providers
  • Understanding of global regulations related to Pharmaceuticals, Medical Devices, Biologics in the context of service offerings
  • Working experience or understanding of external pharmaceutical data standards like pharmacopeia, standard terms, ISO, MedDRA, EDQM etc.
  • Knowledge of regulations, legislation, best practices and guidelines relating to RIMS or compliance initiatives. (i.e. GxP, Annex 11, 21 CFR Part 11, ISO standards etc.)
  • Experience in customer interaction.
  • Able to work independently
  • Fluent in English

Technical Skills

  • Hands-on experience in managing Regulatory Processes, including related IT systems
  • Hands-on experience in using presentation tools like PowerPoint, Visio etc.
  • Ability to effectively transfer the knowledge on RIMS process, Technology, etc. through regular training process such as freshers training, refresher training, new topics and regulatory training etc.

Non Technical Skills

  • Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem resolving skills
  • Worked in the capacity of lead or senior role responsible for project or sub workstream in the past

Competencies

  • Excellent Communication (Writing and Verbal)
  • Customer Focused
  • Organization Skills
  • Drive to deliver superior quality proposals
  • Strong Time management
  • Good Stakeholder management
  • Training abilities

Personal Traits

  • Positive Attitude
  • Initiative and Commitment
  • Leadership Skill
  • Detailed Oriented
  • Team player
  • Focused and sincere
  • Perserverance

Medical Device Regulatory Consultant – Europe, UK, USA

Roles & Responsibilities

  • Maintain, develop, and share your expertise and knowledge on a specific expert area and participate in MDR related forums to understand the latest trends as well as approach prospective clients
  • Actively participate in client bid defense meetings for Medical Device prospective projects
  • Provide advisory consulting services, proactively monitor regulations across regions to advise companies on new regulations
  • Provide SME consulting in the areas of regulatory strategy, submissions and operations
  • As a medical device expert, you will support to build (technical) documentation and design dossiers in support of CE marking, 510(k), or other approval procedures
  • Provide SME consulting for Regulatory compliance according to the current EU Directives (i.e. MDD & IVD), new EU Regulations MDR & IVDR (EU 2017/745 & EU 2017/746), FDA, ANVISA, Heath Canada, MHLW/PMDA & TGA (MDSAP requirements)
  • Lead MDR gap analysis projects and conduct analysis of existing systems, processes and departments in terms of new regulation.
  • For MDR Gap Assessments you will perform the following: Work with stakeholders to identify required changes to compliance processes and updating associated process documentation including Technical, Quality, Clinical, Post-Marketing, Labeling, Economic Operators and other areas
    • Implement improvements to technical files and other documents like Clinical Evaluation Plan (CEP), Clinical Evaluation Reports (CER)
    • Understand current compliance situation of medical device to international standards
    • Suggest and support implementation of changes to organization’s risk management processes
    • Develop device risk assessments with input from clinical and technical experts within the organizations
    • Identify actions required to ensure compliance with ISO 13485, MDSAP and MDR
    • Supporting and conducting updates to labelling, SOPs, work instructions, trending tools and policy documents to ensure compliance with EU-MDR
    • Make updates to labelling, SOPs, work instructions and policy documents to ensure compliance with the client’s corporate SOPs
  • Assist in the development/construction of Technical Files according to the new MDR & STED format with emphasis on developing following documentations:
    • Essential Requirements Evaluation Report to Annex I of MDR & IVDR
    • Risk Management Reports / Documentation to ISO 14971:2012
    • Clinical Evaluation Report development according to MDR & IVDR and/or MEDDEV 2.7.1 Rev 4
    • PMCF Planning Report development according to MDR & IVDR and/or MEDDEV
    • Development of Vigilance Reporting strategies to MDR & IVDR and/or MEDDEV
  • Support regulatory submission projects with submission requirements for appropriate market and product type
  • Establish and maintain a professional and credible relationship with direct clients (customer of Celegence) and indirect clients like Health Authorities, Notified Bodies and other regulatory agencies
  • Responsible for the operational planning of the project and prepares weekly plans for the team which are in line with the project time lines
  • In collaboration with Quality Assurance, ensure that project team members are appropriately trained on all project SOPs, guidelines and documents as required
  • Proactively follow the news and trends in the market to share with the rest of the team
  • You may be asked to support marketing activities, such as webinars, blog writing, as well as business development activities such as presales meetings with prospective clients
  • Supporting internal and external audits as required
  • Provide status reporting to stakeholders according to an agreed communications plan

Education & Experience

Education:

  • Bachelor’s Degree in pharmacy or Regulatory Affairs or any relevant Life Sciences fields. Master’s Degree is preferred
  • RAC certification: Medical Devices is a plus

Experience:

  • Minimum 5 years working experience in the field of medical devices through positions in industry, consultancy or regulatory agencies (Notified Bodies, FDA, EMA), in either manufacturing, R&D, quality or regulatory roles
  • Experience writing MDR compliant Clinical Evaluation Reports and other documents
  • Knowledge of Quality Management Systems implementation to ISO 13485:2016
  • Knowledge of Risk Management Systems based on ISO 14971:2012
  • Experience in creating customer facing materials and conducting workshops as SME
  • Knowledge of Medical Device Regulations related to major health authorities of US, EU, Japan, China, Australia, Brazil, Canada
  • Worked in a client-focused organization as a consultant in the past
  • Hands on experience in managing all regulatory affairs activities and ensuring full regulatory compliance for medical devices
  • Fluent in English

Skills and Competencies

Technical / Functional Skills:

  • Excellent knowledge of MDD/MDR
  • Excellent knowledge of ISO 13485 standards
  • Good understanding of IMDRF requirements for member countries
  • Strong stakeholder management experience

Non-Technical Skills:

  • Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem resolving skills
  • Good knowledge of strategy development and implementation techniques for Medical Device registrations, compliance towards new regulations etc.
  • Possess strong verbal and written communications skills, strategic thinking, ability to influence others & problem resolving skills

Competencies:

  • Excellent Communication (Writing and Verbal)
  • Customer Focused
  • Organization Skills
  • Strong Time management
  • Good Stakeholder management
  • Project management and tracking

Personal Traits:

  • Positive Attitude
  • Initiative and Commitment
  • Leadership Skills
  • Detailed Oriented
  • Team player
  • Focused and sincere
  • Perseverance

Senior Full Stack Developer – US/UK

Celegence is looking for a full stack developer in our US or UK location with 10 years of web application software development experience. This person should be able to manage a team of developers with hands-on experience in both front-end & back-end development.

About the Company

Celegence LLC is a privately owned business based in Chicago, IL with offices in the U.K. and Bangalore. Celegence provides clients with consulting, services, and solutions to support their regulatory affairs operations and strategy. We support companies in ensuring regulatory compliance across the globe by providing both a platform and fully trained resources who understand the regulations and can leverage this knowledge to assist our clients in their day to day operations. We are currently building innovative technology to help our customers achieve efficiencies around global Regulatory compliance.

Celegence strives to be the premier niche provider of Regulatory Affairs services and technology in order to improve outcomes for the life sciences industry. Our primary objective is to provide end to end regulatory solutions that enable life science organization to deliver exceptional patient value.

Roles & Responsibilities

  • Develop applications using React/Node.js/MySQL with web sockets/AJAX
  • Help advise on the technology stack (end to end)
  • Work within a fast paced Agile/Scrum methodology
  • Use SOAP and REST to implement API integrations with other SaaS platforms
  • Experience in enterprise architecture, designing concepts, exposure to different design patterns for UI, Persistence and development of solution
  • Experience with Document Management Solutions like Box with good understanding of its APIs

Education & Experience

  • 6+ years of experience in Node.js, MySQL and AWS, 4+ years in React.js
  • js with Express, MySQL and MongoDB, Passport
  • Microservice Architecture understanding and hands-on implementation
  • Hands-on development experience building 3rd party applications using Box.com e.g. Content Management APIs, Custom APIs, User and Groups security and collaboration, Search, etc.
  • Strong proficiency in JavaScript, including DOM manipulation and the JavaScript object model
  • Experience with popular React.js workflows (such as Flux or Redux)
  • Familiarity with RESTful APIs
  • Knowledge of modern authorization mechanisms
  • Familiarity with modern front-end build pipelines and tools
  • Experience with common front-end development tools such as Babel, Webpack, NPM, etc.
  • Ability to understand business requirements and translate them into technical requirements
  • Working knowledge of containerization
  • Basic knowledge on Kubernetes
  • Knowledge on any NOSQL database Skills
  • Database Schema Design and development
  • Hands on skills with Database Stored Procedures, Views, Database Security

Skills and Competencies

  • Possess strong verbal and written communications skills
  • Ability to influence others & problem resolving skills
  • Ability to work independently
  • Should be a team player
Life Sciences Regulation - Celegence Careers

Competitive Compensation & Benefits

Celegence Growth Company - Life Sciences Regulations

Supportive Work Environment

Celegence Careers - Life Sciences Regulations

Growth Opportunities

Join Our Team

​If you are interested in joining our team, please fill out the form below or email careers@celegence.com and we will contact you for further discussion.

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