Regulatory Affairs Specialist

About ENOVIS

ENOVIS is a medical technology growth company focused on innovative clinically differentiated solutions that improve patient outcomes and transform care workflows. We operate with a culture of continuous improvement and collaboration across international teams in orthopedics and beyond. For more information, please visit

Who We Are

ABOUT ENOVIS

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company’s extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit

What you’ll do

In a newly created role, we are opening a position for a Regulatory Affairs Specialist (H/F) on a permanent contract. Reporting to the VP Regulatory Affairs, your main missions will include:

• Strategic regulatory planning & market access – Define and lead the regulatory strategy for France & International.

• Anticipate changes related to Regulation (EU) 2017/745 on medical devices (MDR).

• Ensure and accelerate time-to-market for products.

• Support and facilitate NPI development in collaboration with R&D.

• Compliance & maintaining certifications – Ensure product conformity (CE marking, technical files, vigilance).

• Oversee relationships with notified bodies.

• Ensure compliance with quality requirements (in relation to QA).

• Lead regulatory audits (internal/ external).

• Interface with authorities & stakeholders – Represent the company with authorities (SNITEM for France).

• Advocate the company’s positions in sector discussions.

• Business support & R&D teams – Guide marketing/sales on regulatory constraints.

• Protect product claims and promotional materials.

• International coordination – Be the France/International point of contact for the VP Regulatory based in the US.

• Translate global requirements into local practice.

• Report international issues to the global team.

• Regulatory watch & transformation – Establish active watch (France + International).

Profile / Qualifications

• Master-level degree (pharmacist, biomedical engineer or scientific background).

• 10 to 15 years in regulatory affairs for medical devices (MedTech).

• Solid expertise of MDR and interactions with regulatory authorities.

Key Skills

• Strategic vision, ability to connect regulatory issues to business impact.

• Cross-functional leadership and influence.

• Rigorous execution and strong project management.

• Excellent communication skills with technical and non-technical stakeholders.

• Pragmatic, solution-oriented approach.

• Comfort in matrix environments.

• Credible leadership backed by strong technical expertise.

Start date: asap

Equal Opportunity

In compliance with French law, Enovis is committed to equal opportunity in employment. Decisions regarding employment are based on merit, qualifications, and business needs, with policies that promote equal treatment for all employees and applicants without discrimination based on race, color, religion, national origin, sex, sexual orientation, gender identity, age, veteran status, disability, or any other characteristic not related to qualifications or performance. This applies to all aspects of employment including recruiting, hiring, assignment, compensation, training, promotion, transfers, layoffs, discipline, and separation.

Equal Employment Opportunity