Regulatory Affairs Specialist – Hybrid (France)

About the role

Enovis is seeking a Regulatory Affairs Specialist to define and execute regulatory strategy for France and international markets. The role works closely with R&D, QA, and commercial teams to ensure compliance and enable timely product launches in a MedTech environment.

Key responsibilities

• Define and implement regulatory strategy for France and selected 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 introductions by providing regulatory guidance to R&D.
• Advise Marketing and Sales on product claims, labeling, and promotional materials.
• Monitor regulatory changes and coordinate timely implementation across the organization.

Required profile

• Bachelor’s degree in pharmacy, biomedical engineering, or a related scientific field.
• 3–4 years of experience in regulatory affairs within MedTech or medical devices.
• Strong knowledge of EU MDR and experience interacting with regulatory authorities.
• Fluent in English and French.

Required skills

• EU MDR compliance expertise.
• CE marking processes.
• Regulatory affairs documentation and liaison with Notified Bodies.