Define and implement regulatory strategy for France and international markets
Ensure compliance with EU MDR (2017/745), CE marking, technical documentation, and vigilance requirements
Manage interactions with Notified Bodies and regulatory authorities
Support product development and new product introduction (NPI) with R&D
Provide regulatory guidance to Marketing and Sales teams on claims and materials
Act as key liaison with the US-based Regulatory Affairs leadership team
Monitor regulatory changes and ensure timely implementation

Bachelor’s degree in pharmacy, biomedical engineering, or related scientific field
3–4 years of experience in regulatory affairs within MedTech or medical devices
Good knowledge of EU MDR and regulatory authority interactions
Fluent in English and French

Regulatory Affairs Specialist

Key skills