Regulatory Affairs Consultant MD (M/F)

To support our growth and the development of new projects, we are looking for a Regulatory Affairs Engineer (M/F) for our clients in the Electromedical Devices sector.

Your Missions:

• Define and lead the EU (MDR) and US (FDA) regulatory strategy.
• Compile/update technical files (CE, 510(k)/PMA).
• Ensure Quality System compliance (ISO 13485, 21 CFR 820) in collaboration with the quality team; lead internal audits, MDSAP, and FDA inspections.
• Manage interactions with notified bodies, competent authorities (ANSM, FDA, etc.), and external partners.
• Contribute to regulatory monitoring (MDR, IVDR, FDA guidances, ISO, IEC) and the continuous update of internal procedures.

Profile sought:

• Master's degree (engineer, pharmacy, biomedical, or equivalent) with a minimum of 3 years of experience in medical device regulatory affairs.
• Solid practice of CE (MDR) and FDA (510(k) or PMA) market placements for products combining hardware and software.
• Mastery of ISO 13485, ISO 14971, IEC 62304, IEC 60601, IEC 62366 standards and FDA/IMDRF cybersecurity requirements.
• Experience in managing technical documentation and audits (notified body, MDSAP, FDA).
• Fluent professional English (written & oral).
• Leadership, rigor, ability to work in a multidisciplinary and international environment.

This job offer is open to all profiles.