Regulatory Affairs Manager
il y a 5 jours
OverviewTitle: Senior Consultant – Device Regulatory Documentation & ComplianceLocation: Paris (3 days onsite - 2 WFH)The CompanyWe believe great work happens when brilliant minds come together with a shared purpose. This biopharma company is known for its dedication to employee happiness, its collaborative environment, and its passion for bringing groundbreaking combination products to market. With a culture that fosters community, learning, and innovation, this is a place where experts thrive—and where your voice will truly matter.The OpportunityDo you love working in collaborative environments where your leadership makes a difference?Are you passionate about crafting regulatory strategy for cutting-edge medical devices and combination products?Do you dream of taking ownership, mentoring teams, and shaping documentation processes that define global standards?Are you looking for the chance to build something meaningful, in a fun and engaging setting?This is your opportunity to step into a senior leadership role with high visibility and influence. As the Senior Consultant for Device Regulatory Documentation & Compliance, you will take the lead on critical global submissions for medical devices and combination products. You’ll be at the center of regulatory strategy, partnering with cross-functional teams to drive compliance, build documentation systems, and respond to regulatory authorities with confidence.ResponsibilitiesLead and mentor the Regulatory Documentation & Compliance team, fostering a high-performing, collaborative culture.Develop and maintain essential regulatory documentation (DHF, DMR, etc.) for combination product submissions in the US and EU.Co-operate with Product Development, Quality Assurance, MSAT, and Regulatory Affairs to build regulatory strategies aligned with project priorities.Monitor regulatory changes and advise the organization on innovative ways to stay compliant.Prepare and lead Design Reviews, and guide internal teams with best practices.Support interactions with regulatory agencies and contribute documentation for INDs, IMPs, BLAs, MAAs, and more.Define, improve, and implement systems that make regulatory integration more efficient and traceable.Play a key role in risk management and post-market surveillance documentation.Qualifications5–7 years of experience in medical devices and combination products, with a strong compliance/documentation track record.Deep understanding of ISO 13485, 21 CFR Part 820, 21 CFR Part 4, and EU MDR.Fluent English communication (written and spoken).How to applyIf you are interested in this exciting role, please send your application directly to veronica@elemed.euPlease note: Due to the high volume of applications we sometimes receive, our team might not be able to contact each applicant individually regarding the status of their application. If you do not hear from us after 10 days, please consider your application unsuccessful.Check out more opportunities: Visit https://www.elemed.eu/vacancies/Position detailsSeniority level: Mid-Senior levelEmployment type: ContractJob function: Quality Assurance, Manufacturing, and Business DevelopmentIndustries: Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Hospitals and Health CareWe’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr
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