Regulatory Affairs Officer

Why join us?

Joining our group means participating in an exciting human and technological adventure: ensuring the compliance of our medical devices to reduce risks related to radiation and advance health.

With us, rigor goes hand in hand with good humor! You will join a human-sized, dynamic, accessible, and benevolent team, where teamwork, mutual support, and a great atmosphere are at the heart of our daily lives.

What we offer you:

• The richness of a multi-company environment: 6 "company" brands, 6 maturity stages, and different products and services (consulting and expertise, training, medical devices and IVDs)! An ideal playground if you enjoy versatility, diverse subjects, and stimulating challenges.

• The package: attractive remuneration, meal vouchers, profit-sharing bonus, works council, 50% of your public transport pass and/or bike rental for your commute to headquarters...

• A comprehensive onboarding program: For a successful start and a genuine skills development policy.

• A unique atmosphere recognized by our employees: Mutual support, horizontal management, transparency, team events... and many other elements that earn us a rating of 4/5 on Glassdoor!

Your main responsibilities:
Reporting to the Quality Assurance Director, you will ensure the regulatory compliance of our products and services throughout their life cycle, while contributing to the maintenance of our Quality Management System:

Regulatory Affairs & CE Marking:

• Compile, update, and verify the conformity of technical files for obtaining and maintaining CE marking, as well as international registrations (import/export).

• Administer the management of Unique Device Identifiers (UDI) and populate regulatory databases (e.g., EUDAMED).

• Approve the regulatory compliance of labels, instructions for use, and promotional materials.

• Support the sales team with distributors and manage change requests related to devices.

Post-Market Surveillance (PMS) & Vigilance:

• Develop, manage, and write post-market surveillance plans and reports.

• Process incident reports, write reports for health authorities, and initiate corrective actions in response to complaints.

Quality, Risk Management & Continuous Improvement:

• Participate in product risk analyses and manage key performance indicators (especially customer satisfaction).

• Participate in or lead audits (QMS and suppliers) and follow up on associated action plans.

• Write and structure procedures specific to regulatory affairs in close collaboration with Quality Assurance.

Regulatory Watch:

• Conduct regulatory and normative watch (OJEU, ANSM, EMA, FDA...) and disseminate impactful news within the company.

  Your pride if you succeed with us?
  You will directly contribute to the expansion of an innovative, fast-growing French group and, most importantly, to the reduction of radiation-related risks!

Your profile:

Higher education degree (Bac+5) (Specialized Master's in Medical Devices, ideally with a background in biology) or 3 to 5 years of experience in Regulatory Affairs / QA.

You have a perfect command of the regulatory framework for Medical Devices and IVDs (MDR 2017/745, IVDR 2017/746) as well as industry standards (ISO 13485, ISO 14971 for risk management). With a solid scientific background, you communicate easily with R&D, production, and quality teams. You have excellent writing skills to structure and maintain technical documentation while ensuring flawless traceability for notified bodies. Your professional English is fluent both written and spoken.

Analysis, proactivity, and organization allow you to evaluate complex data, manage priorities, and anticipate normative changes through constant strategic watch. Pedagogical and diplomatic, you know how to simplify regulatory requirements internally and interact with confidence with health authorities.

Beyond your rigor, your dynamism, enthusiasm, and interpersonal skills will make the difference in moving projects forward as a team. Ready to take on the challenge?

If you are looking for a stimulating role in a group where a great atmosphere prevails, join us quickly! Send us your application.

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