Executive RA, euMDR Technical File

About the Role

Support regulatory affairs and the preparation and maintenance of euMDR technical files for Mitra's medical-device portfolio.

Key Responsibilities

• Prepare and maintain technical documentation aligned with EU MDR requirements.
• Coordinate with manufacturing and quality teams on compliance evidence.
• Support audits, submissions, and post-market surveillance documentation.

What We're Looking For

• 3 to 5 years in regulatory affairs for medical devices.
• Working knowledge of EU MDR technical-file requirements.
• Attention to detail and strong documentation discipline.