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

Regulatory Affairs – SME

Employment Type: Full Time

Celegence is looking for a Regulatory Affairs SME with 5 – 7 years of relevant 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

  • Responsible for using and updating RA systems like Regulatory Information Management system (RIMS), Document or Content Management System and eCTD submissions
  • Manage various activities in RIMS database under product life cycle management (Registration, Variation, Renewals and submission)
  • Prioritize target activities and Produce high quality deliverables
  • Ensure targets and compliance reporting requirements are achieved in accordance with established timelines for key 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 Client
  • Support implementation of Regulatory Affairs systems as per Client or Partner projects
  • Support peers and resolve issues related to 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 to ensure compliance and share with Client
  • Effective usage of applicable RA electronic systems
  • Accountable for resource utilization, management and competency development of the teams assigned with inclusion at Individual level role
  • Understands and will abide by IQMS policy and processes of the company
  • Lead/Contribute to implementation of Regulatory Information Management system / platform and associated data processes & data operations
  • Ensure customer success throughout the engagement
  • Drive end to end IDMP data preparation & readiness: data assessment at source, data remediation, data transformation, data enrichment and data completeness

Education & Experience

Education:

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

Experience:

  • Minimum 5 – 7 years of relevant Regulatory Affairs experience required
  • Provide subject matter expertise on ISO IDMP Standards, EU Implementation Guide and SPOR
  • With good understanding of regulatory information management & associated business processes, provides expertise in managing IDMP data & processes in a global RIMS platform
  • Skilled in Regulatory Information Management
  • Business processes experience and 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 business process areas and training delivery experience is a plus
  • Familiar with current knowledge of electronic document and submission requirements applicable to the EU, US, and global regulatory environments
  • Participated in the implementation of new health authority guidelines and rules relevant to regulatory submissions
  • Experience coordinating with artwork supply, artwork review and approval of artwork for labelling variations
  • Understanding of global regulations related Pharmaceutical, Medical Device, 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 and ensure customer success throughout the engagement
  • Able to work independently

Skills

Technical Skills

  • Hands on experience related to Regulatory Processes including related IT systems
  • Hands of experience on presentation tools like PowerPoint, Visio 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

Personal Traits

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

Bookkeeper/Accounting Assistant – Chicago, IL

Employment Type: Full Time

Celegence is looking for a Bookkeeper/Accounting Assistant in Chicago, IL region with 5 or more years of bookkeeping and accounting 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

  • Reconcile the company’s bank statements and bookkeeping ledgers
  • Prepare invoices for customers and manage payments collection process
  • Keep track of upcoming monthly/quarterly/annually invoices for customers
  • Receive and record bills and prepare report of upcoming payments
  • Maintain and promote excellent vendor relations
  • Complete analysis of employee expenditures
  • Manage income and expenditure accounts
  • Generate the company’s financial reports using income and expenditure data
  • Monitor the company’s finances based on financial status
  • Document transaction details
  • Generate financial reports
  • Fact-check accounting data
  • Notify senior staff of any accounting errors
  • Record financial transactions
  • Prepare semi-monthly payroll and track payroll data
  • Manage customer contracts and SOW timeframes, issue timely invoices, and review collection payments

Education & Experience

Education:

  • Bachelor’s degree or higher in Finance & Accounting, or equivalent work experience
  • QuickBooks Online Certification, preferred

Experience:

  • 5 or more years of bookkeeping and accounting experience

Skills

Technical Skills

  • In depth knowledge and experience with QuickBooks Online (QBO)
  • Initiate and manage financial/accounting software used by the company, QBO and Excel required
  • Accounts Receivable, Accounts Payable, G/L, Billing, Invoice Management, Payroll, etc.

Non-Technical Skills

  • Strong knowledge of all Microsoft Office applications
  • Excellent data entry skills, preferred
  • Customer service skills

Competencies

  • Strong written and verbal communication skills
  • Ability to communicate complex data in a clear way
  • Problem solving and complex thinking skills
  • Ability to meet deadlines
  • Works well under pressure and responds well to tight deadlines
  • Ability to work in a team and on your own
  • Experience using time management skills such as prioritizing, organizing, and tracking to manage meeting deadlines and multiple projects with varying completion dates
  • Accomplish goals with little or no supervision, depending on self to complete objectives and determine when escalation of issues is necessary

Personal Traits

  • Works with integrity and ethically
  • Upholds organizational values
  • Sincere, focused, and detail oriented
  • Positive Attitude
  • Ability to manage, motivate, and inspire people to embrace change

Senior Financial Analyst – Accountant

Employment Type: Full Time

Celegence is looking for a Senior Financial Analyst – Accountant with 8-12 years of work experience in finance and accounting.

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

  • Bookkeeping, JE’s, closing entries and BRS reports Periodically
  • Accounts Finalization and Books closure on a Monthly/Quarterly/Yearly basis
  • Review Cost-plus billing and local country compliance
  • Preparation of entity-wise Financial Projections, Budgets including analysis like Variance report
  • Preparation of profit and loss statement for the company(ies) and for customer(s) to analyze which customer(s) is under/over the gross margin
  • Handling AR, Collection, Billing as per US-GAAP standards and contract/SOW management
  • Preparation of Cash-Flow statements and forecasts
  • Preparation of CapEx & OpEx Report periodically
  • Fixed Assets: Capitalization, Depreciation run and FA Register maintenance
  • Handling Internal and Statutory Audits independently
  • Exposure to Indian statutory related compliances like GST, Income Tax/TDS, ROC, EPF and STPI
  • Assisting in GST Monthly/Quarterly E-filing & GST Refund Procedures, as needed
  • Assisting in Indian Payroll and related compliance, as needed

Education & Experience

Education:

  • Accounting/Commerce Degree, Bachelor’s Degree in Finance & Accounting
  • MBA in Finance Preferred

Experience:

  • Should have minimum 8-12 years of experience in Finance & Accounting
  • Able to work independently

Technical Skills

  • Finance, Accounting, MIS, Budget, Projection, AR, AP, Audit, GST, TDS, Billing, ROC, PF PT and Payroll compliances, cash flow
  • Knowledge and experience with Tally 9
  • Knowledge and experience with QuickBooks Online Preferred
  • Ability to learn QuickBooks Online if no prior experience

Non-Technical Skills

  • Online accounting exposure
  • Strong / advance knowledge MS Excel and various formulas
  • Strong knowledge MS office
  • Knowledge or exposure of Dutch language Preferred

Competencies

  • Good communication skill
  • Teamwork
  • Problem solving and complex thinking skills

Personal Traits

Academic, Quick, Accurate, Positive Attitude, Initiative and Commitment, Versatile, Realistic, Detailed Oriented, Team player

Senior Devops Engineer

Employment Type: Full Time

Celegence is looking for a Senior Devops Engineer with 6-8 years of work experience in devops.

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

  • Deploy and maintain critical applications on cloud-native microservices architecture
  • Implement automation, effective monitoring, and infrastructure-as-code
  • Deploy and maintain CI/CD pipelines across multiple environments
  • Support and work alongside a cross-functional engineering team on the latest technologies
  • Iterate on best practices to increase the quality & velocity of deployments
  • Sustain and improve the process of knowledge sharing throughout the engineering team
  • Have on call responsibilities in rotation with the engineering team
  • Analysis of the current infrastructure in use and developing plans for enhancements and improvements
  • Defining and setting development, test, release, update, and support processes for DevOps operation
  • Identifying and deploying cybersecurity measures by continuously performing vulnerability assessment and risk management
  • Writing documentation for infrastructure and network topology
  • Work in close coordination with the development and operations team such that the application is in line with performance according to the customer’s expectation
  • Cloud deployment and management
  • Performance assessment, monitoring and recommending performance enhancements
  • Infrastructure management
  • Root cause analysis and incidence management
  • Encourage and build automated processes as and when applicable

Education & Experience

Education:

  • BSc in Computer Science, Engineering, or relevant field

Experience:

  • 6-8 years of experience in DevOps Engineer or similar software engineering role
  • Experience working on Linux based infrastructure

Skills

  • Working knowledge of various tools, open-source technologies, and cloud services
  • Hands-on experience in building, designing, and maintaining cloud-based applications with AWS, Azure or Google Cloud Platform
  • Hands-on experience to build and handle VM’s, Containers utilizing tools like Kubernetes, Docker, etc.
  • Awareness of critical concepts in DevOps and Agile principles
  • Excellent troubleshooting
  • Experience maintaining and deploying highly-available, fault-tolerant systems at scale
  • A drive towards automating repetitive tasks (e.g. scripting via Bash, Python, Ruby, etc)
  • Expertise with AWS (e.g. IAM, EC2, VPC, ELB, ALB, Autoscaling, Lambda)
  • Version control system experience (e.g. Git)
  • Experience implementing CI/CD (e.g. Jenkins, TravisCI)
  • Operational (e.g. HA/Backups)
  • Experience with configuration management tools (e.g. Ansible, Chef)
  • Experience with infrastructure-as-code (e.g. Terraform, Cloudformation)
  • Bachelor or master’s degree in CS, or equivalent practical experience
  • Effective communication skills

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

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

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

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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