Regulatory Affairs Consultant (12 months)

I'm partnering with a well‑established medical device manufacturer in Lyon who is looking for an experienced

Regulatory Affairs Consultant

to support a series of key projects over the next 12 months. This is a great opportunity for someone who enjoys hands‑on regulatory work, cross‑functional collaboration, and helping drive products through complex MDR requirements.

What you'll be doing:

Leading preparation, review, and maintenance of regulatory submissions for the EU (MDR) and select international markets.

Managing updates to technical documentation, including design dossiers, risk management files, clinical evaluation reports, and labelling.

Supporting internal teams with regulatory interpretation and providing guidance throughout product development and lifecycle management.

Performing regulatory gap analyses, coordinating remediation activities, and ensuring compliance with the latest guidance and standards.

Acting as a contact point for notified bodies and assisting with audits, questions, and follow‑up actions.

Monitoring regulatory changes and advising stakeholders on potential impact to product portfolios.

What they're looking for:

Solid background working exclusively within medical devices, preferably with Class IIb/III devices.

Proven experience with

EU MDR submissions , technical files, and interactions with notified bodies.

Someone comfortable working independently while collaborating closely with QA, R&D, Clinical, and Project Management teams.

Strong communication skills and a practical, solution‑focused mindset.

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