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.
Celegence is an Equal Employment Opportunity Employer.
All employment decisions at Celegence are made without regard to age, race, creed, colour, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law. Celegence is committed to providing a positive work environment as a part of the core Organizational value and is free from discrimination and harassment, and we will not tolerate any form of unlawful discrimination or harassment.
Please read Celegence’s Privacy Policy for more information on how we process your data during the Recruiting and Hiring process.
Project Delivery Management
Regulatory Affairs Data Management
Compliance Data Management
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
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.
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.
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?
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.
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.
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.
Current Job Openings at Celegence
Marketing Manager
Job Location: United Kingdom
Role: Remote
Reporting to: Marketing Director
About the Company
Celegence is a privately owned business based in Chicago, IL with offices in London, Waalwijk, and Bangalore. We provide clients with consulting services, and solutions to support their regulatory affairs operations and strategy. Our fully trained resources support companies in their day-to-day operations by ensuring regulatory compliance across the globe, leveraging their expert knowledge – as well as our technology and automation to improve compliance.
Celegence’s vision is to be the premier niche provider of regulatory services and solutions, 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 organisations to deliver exceptional patient value.
Role Description
The Marketing Manager will work with the Marketing Team to organise and implement offline and online marketing activities to B2B clients, ensuring the integrity of the Celegence brand throughout all activities and communications.
Working within the Marketing Team, they will ensure that all marketing activities – including in-person events, webinars, blogs, email, and social media activities are in line with the overall strategic objectives and implement and monitor the success of marketing campaigns.
One of the main marketing goals is to identify, pursue, and capture prospects through these channels, so a strategic / tactical plan will be needed. On-going content generation will also form a part of this role, as well as other offline marketing support to assist the team.
Responsibilities
- Help to plan and organise marketing initiatives, ensuring our brand is always at the forefront and that all campaigns are within budget.
- Learn the customer needs, buyer journey, language, and overall mindset of our target market. Turn these insights into compelling messaging to help achieve our new & existing customer growth objectives.
- Plan and organise sales and marketing conferences, industry trade shows and various types of marketing activities to meet our growth and revenue objectives.
- Assist the Head of Digital and team in planning, managing and implementing blogs, webinars and podcasts.
- Understand the marketing tool landscape – including Salesforce, Pardot, 6Sense, Analytics Review Weekly and Wiza.
- Conduct market research in order to identify local market requirements and future campaigns, presenting your findings to the Marketing Director.
- Create strong content, helping to attract and nurture customers and prospects through both offline and online activity, helping to attract and nurture customers and prospects through online activity and targeted email campaigns.
- Help to build and implement the social media strategy to increase brand awareness and customer retention, driving traffic to the website or microsites, generating leads into sales.
- Work with the Head of Digital and team to keep social media channels and local areas of the website up-to-date, helping to build brand awareness and customer retention.
- Help to create videos for new products, features and testimonials in conjunction with the Marketing Team.
- Continuously research and keep an eye on the competition, documenting competitor analysis and making sure the business is at the forefront of the industry.
- Constantly be on the lookout for new marketing opportunities or ways to promote the Celegence brand.
- Release communications – Be the de facto Celegence expert and translate key product releases into communications and launches that excite internal and external audiences.
- In conjunction with the Marketing Team, work with our external design / print companies to create design elements and print when needed.
- Proactively establish and maintain effective working team relationships with all support departments.
- Help the MD with other offline marketing requirements when needed.
- Work with the Marketing Team and key stakeholders to help to collate content for the communications plan, ensuring SME’s deliver all elements in a timely manner.
Qualifications
- 5+ years’ experience in marketing, with digital experience
- Strong knowledge of marketing principles, strategies, and tactics
- Significant experience in planning events, such as trade shows.
- Experience in developing and executing marketing campaigns
- Proficiency in digital marketing channels and tools
- Excellent analytical and problem-solving skills
- Ability to interpret market trends and consumer insights
- Strong written and verbal communication skills
- Ability to work independently and remotely
- Experience in the Life Sciences industry is a plus
- Bachelor’s degree in Marketing, Business, or a related field
- CIM qualified is desired but not essential
- Marketing experience within a B2B environment
Benefits
We offer a competitive compensation package, comprehensive benefits, and a supportive work environment that fosters professional growth and development. Join our team and be part of an organization that is making a real difference in the lives of patients worldwide.
Director – Regulatory Data Management
Job Location: Netherlands
Role: Full Time, On-Site
Reporting to: Chief Delivery Officer
About the Company
Our company is a rapidly growing innovator in the healthcare sector, committed to transforming the healthcare landscape through cutting-edge solutions. Celegence Provides Services and Solutions to Support the Life Sciences Industry with Regulatory Affairs Operations and Strategy. We are dedicated to improving patient outcomes through intelligent regulatory compliance. We support companies in ensuring their regulatory compliance across the globe by providing trained resources, knowledge, and technology to assist our clients in their day-to-day operations.
Roles & Responsibilities
- The Director Regulatory Data Management is responsible for delivering high quality services and projects to Celegence customers for data management.
- The position leads a team specialized in the submission and reporting of data (primarily) describing Medicinal- and pharmaceutical products, Organizations and Substances.
- Focus is on ensuring the highest possible data quality and compliance with existing guidance, regulations, and data standards.
- The position closely cooperates with the Regulatory Affairs (RA) department of Celegence customers and contributes to the correct use and implementation of data to support their business processes.
- Typical activities include providing consultancy and other support related to process development, data cleansing and remediation activities, vendor selection and system implementation.
- The position coordinates daily operations, project and resource planning for the Data Management group and establishes and maintains an excellent working relationship with Celegence customers.
- The position can also be involved in the development of the in-house developed and maintained solutions (such as Dossplorer™, Dosscriber ™ and Hosted platform). This position on a need basis function as a Subject Matter Expert, where the responsibilities are ensuring translating business needs to functional requirements and supporting Software Development activities.
- This position will support pre-sales and marketing initiatives related to regulatory data management function.
- The position will act as line manager for individual team members and acts as a coach on achieving goals and developing necessary skills of all team members within the department.
Key Responsibilities & Tasks
- Coach Team Members
- Coach on achieving goals and develop skills of individual team members.
- Resolve conflicts
- Team Planning and Organization
- Identify team goals, resource planning and prioritizes work activities
- Organization of team roles and responsibilities
- Volunteers to assist team with overflow duties
- Project and Services Delivery
- Ensure high quality projects and services are delivered to Data Management customers.
- Consults with team members to ensure targets and deliverables are met.
- Provides consultancy on data management related aspects in business process development and implementation
- Vendor Selection and System Implementation
- Evaluate and validate software supporting regulatory information management.
- Leading role in implementing regulatory information management solutions and vendor selection.
- Leading/ supporting data migration and remediation tasks
- Quality Management System
- Responsible for the Data Management related processes and procedural documents.
- Participates in the development, maintenance and improvement of procedural documents and templates to support the activities mentioned above.
- Track Regulatory Documents, Publications, and Other Related Materials
- Proactively consulting and checking information sources for new, changed, and updated materials. For example: new regulatory guidance or data standards
- Data Management
- Monitor data quality and initiate mitigating and corrective activities to improve data quality.
- Ensure compliance with guidelines and regulations.
- Ensure and promote correct use of data.
- Ensure timely and valid submission of electronic data submissions
- Solution Development Support
- Support technical solutions for regulatory data management as SME.
- Implement tech enabled services by adopting technology solutions to increase efficiency, quality and consistency.
Formal Education
- Higher professional education (or combination of education and working experience to an equal level), preferred in Life Sciences.
Experience
- Expert knowledge of Regulatory Affairs, in particular regulatory information management, with at least 10+ years of adequate professional experience
- Knowledge and experience of the drug development process, regulatory filing guidelines and electronic submissions
- Experience with data management tools and platforms relevant to the life sciences industry
- Experience with software development is a plus.
Qualifications: General Soft Skills
- Affinity with Information Technology and automation
- Strong Leadership abilities
- Good organizational skills, including efficiency and collaboration in a team environment.
- Proficiency with computer skills, including MS Office and Adobe Acrobat
- Ability to manage and deliver through others in a matrix environment.
- Ability to work within a demanding environment with a strong focus on quality and timelines.
- A passion for data quality and a commitment to continuous improvement.
- Eager to learn an array of technical tools.
- High analytical skills
- Flexible, able to adapt to emerging situations.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good knowledge of English (spoken and written)
- Quality focused by transparent systematic and consistent approach.
- Ability to work concurrently on multiple projects, each with specific features that may differ from project to project.
Benefits
We offer a competitive compensation package, comprehensive benefits, and a supportive work environment that fosters professional growth and development. Join our team and be part of an organization that is making a real difference in the lives of patients worldwide.
To Apply
Please submit your resume and a cover letter highlighting your relevant experience and qualifications. We are an equal opportunity employer and value diversity in our workforce.
Senior Medical Writer
Job Location: Bangalore, India
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
- 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
Technical/Functional 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
Personal Traits
- Positive Attitude
- Initiative and Commitment
- Detail Oriented
- Team player
- Focused and sincere
- Perseverance
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
Senior Associate II – Publishing & Submission
Job Location: Bangalore, India
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
- Member of the P&S and RIMS Centre of Excellence team responsible for the Lifecycle Management of assigned products.
- Document level Publishing: Author and Publish the technical, regulatory documents based on the client’s product requirements.
- Submission Level Publishing: Compiles the dossier in the required format for submission to the relevant agencies.
- Responsible for using and updating RA systems like Regulatory Information Management system (RIMS), Document or Content Management System and eCTD submissions.
- Manage various activities 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 training provided by the Client, and regular self-trainings; archive training certificates/records.
- Flexible to work in shifts.
- Assist and support internal audits performed by the Client.
- Support implementation of Regulatory Affairs systems as per Client or Partner projects.
- Understands and will abide by ISMS policy and processes of the company.
Education
- Master’s Degree in pharmacy or Regulatory Affairs or any relevant Life Sciences fields.
- Japanese language reading and writing ability is a must.
- RAC certification is a plus.
Experience
- Minimum 3-5 years of relevant Regulatory publishing and submission and Regulatory Information Management Systems experience required.
- Understanding of global regulations related to Pharmaceuticals, Medical Devices, and Biologics in the context of service offerings.
- Experience in creating customer-facing materials.
- Able to work independently.
- Fluent in English and Japanese.
- Chinese – Mandarin language preferred.
Technical/Functional Skills
- Hands-on experience related to Regulatory Processes, including related IT systems, including Document Level Publishing and Submission Level Publishing
- Regulatory Information Management Systems (RIMS)
Personal Traits
- Positive Attitude
- Initiative and Commitment
- Detail Oriented
- Team player
- Focused and sincere
- Perseverance
Competencies
- Good Communication (Writing and Verbal)
- Customer focused
- Drive to deliver superior quality proposals
- Strong time management
- Proactive and solution orientation
Soft Skills
- Possess strong verbal and written communication skill
- Strategic thinking
- Ability to influence others
- Problem-solving skills
HR & Office Coordinator
Employment Type: Full Time, On-Site
Job Location: Waalwijk, Netherlands
About the Company
Our company is a rapidly growing innovator in the healthcare sector, committed to transforming the healthcare landscape through cutting-edge solutions. Celegence Provides Services and Solutions to Support the Life Sciences Industry with Regulatory Affairs Operations and Strategy. We are dedicated to improving patient outcomes through intelligent regulatory compliance. We support companies in ensuring their regulatory compliance across the globe by providing trained resources, knowledge, and technology to assist our clients in their day-to-day operations.
Roles & Responsibilities
Recruitment & Onboarding
- Support in local recruitment process (posting vacancies on relevant portals, first-screening, scheduling interviews)
- Support with new joiner onboarding (e.g. hand-out of office keys, laptop preparation, etc.)
- Completing mandatory documents for personnel files
- Registering colleagues with insurers, pensions and HR systems.
- Initiating onboarding with relevant departments (access, rights, functional orientation etc.)
Off-Boarding & Exit Management
- Support the off-boarding processes (e.g. return of equipment).
- Confirming terminations of employment
- Deregistering colleagues from insurers and pensions
- Initiating offboarding at involved departments (access, rights, etc.)
Office Administration
- Greeting visitors and providing general administrative support to our employees
- Meeting facilitation (e.g. taking notes during general)
- Coordinating & Organizing social events at site
- Oversee maintenance of office and equipment. (e.g. contact with cleaning company, office supply, waste management, printer maintenance)
- Support with administrative activities in the DM, RA, P&S
- Full assistance with conference registration, hotel booking, visa requests, etc.
HR Support
- Answering colleagues and managers regarding salaries, vacation days, contract changes, sick reports, parental leave, and more
- Daily management of the HR mailbox, including processing HR changes and absence registrations
- Assisting with projects such as subsidy applications, updating the employee handbook, improving employment conditions
- Providing support for absenteeism prevention, vitality, employee satisfaction surveys and automation of repetitive tasks.
- Identifying opportunities for improvement in HR processes and making improvement proposals
Qualifications
- Completed HBO education
- Have around 3-5 years of experience in an administrative HR role
- Up-to-date knowledge of employment law and the Gatekeeper Act
- Strong and proactive with independent decision-making skills
- Accurate and service-oriented with a passion for results-oriented work
- Experience with NMBRS and MS Office is a plus
Benefits
We offer a competitive compensation package, comprehensive benefits, and a supportive work environment that fosters professional growth and development. Join our team and be part of an organization that is making a real difference in the lives of patients worldwide.
To Apply
Please submit your resume and a cover letter highlighting your relevant experience and qualifications. We are an equal opportunity employer and value diversity in our workforce.
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
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
Competitive Compensation & Benefits
Supportive Work Environment
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.
