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Open nowFirst seen 9 days ago

Spécialiste Affaires Règlementaires

Talents Solutions4 open roles

Where
Besançon, France
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Your applicationOpen nowSpécialiste Affaires RèglementairesTalents Solutions · Besançon, France

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  2. CV RocketCV written for this posting.

  3. 25 readersRecruiter, hiring manager, skeptic. Round after round.

  4. CV RocketApplied on Talents Solutions's own form.

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The clock on this job

Early applications get read.

13.1% of postings close within 7 days. Measured by our own scanner across the market.

Share of postings closed within
  1. 2.2%1 day
  2. 4.7%3 days
  3. 13.1%7 days
  4. 21.1%14 days
  5. 35.7%30 days
  6. 58.7%60 days
This job: first seen 9 days ago

The posting

THE OPPORTUNITY

We are recruiting a Regulatory Affairs Specialist to join an innovative MedTech company developing highly complex medical devices, currently in a clinical investigation phase.

This is a strategic RA position with strong exposure to EU MDR, CE marking, clinical activities, and Software as a Medical Device (SaMD).

Ideal for a regulatory professional looking for technical depth, ownership, and real project impact.

RESPONSIBILITIES

As Regulatory Affairs Specialist, you will:

  • Monitor regulatory and standards evolution and ensure integration into development programs and the Quality Management System
  • Review R&D and manufacturing evidence to ensure compliance with regulatory and normative requirements
  • Prepare and coordinate regulatory documentation, including: GSPR Technical Documentation Declarations of Conformity CE marking and other market submission files
  • Manage submissions to authorities and notified bodies, including Q&A coordination
  • Support clinical investigation activities (Investigator Brochures, user information documents, authority interactions)
  • Lead clinical evaluation activities and post-market clinical follow-up
  • Ensure post-market surveillance (PMS) and vigilance activities
  • Handle administrative registrations (ANSM, EUDAMED, etc.)
  • Contribute to the development and continuous improvement of Regulatory Affairs processes within the QMS

REQUIREMENTS

You bring:

  • Solid experience with EU MDR 2017/745
  • Strong understanding of notified body expectations and regulatory interpretations
  • Experience in medical device development environments
  • Excellent writing skills and strong documentary rigor
  • Fluency in English (written and spoken)
  • A practical, solution-oriented mindset and ability to work cross-functionally
  • Knowledge of FDA or other international registrations is a plus
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