Spécialiste Affaires Règlementaires

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
• 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
• 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