Regulatory Specialist

This position is a maternity leave replacement from February to October 2026.

The Regulatory Specialist supports global regulatory activities to ensure medical devices comply with applicable regulations and standards throughout the product lifecycle. This role collaborates closely with Clinical, Quality, Operations, R&D and Marketing to support approvals and ongoing regulatory compliance.

• Hands‑on support with the Development, Quality and Clinical teams to prepare technical documentation in compliance with country specific regulations.
• Maintain submission documentation to global regulatory bodies.
• Maintain applicable standards list and traceability between technical documents and applicable standards.
• Manage Packaging and Labeling requirements.
• Perform routine regulatory monitoring and coordinate with Subject Matter Experts the impact analysis of new/updated standards.
• Support regulatory audit and inspection readiness.

• Master’s degree in biomedical engineering or equivalent, with a specialization in Regulatory.
• 1-3 years of experience in Medical Device regulatory. Experience with Active Implantable Devices is a plus.
• Hands‑on experience with the use of quality management system (ISO 13485), Risk management (ISO 14791), Biocompatibility ISO 10993 series and other horizontal standards such as ISO 62304, IEC 60601, ISO 62366, ISO 15223‑1 etc.
• Understanding of Regulatory processes in medical devices;
  Medical Device Regulation and FDA pathway.
• Experience with EU MDR technical documentation preparation and FDA submission packages.
• A high energy, fast‑learner, self‑motivated, pro‑active personality able to work in a diverse team within a fast growing company; willing to help colleagues.
• Fluent in English, proficiency in French is highly desirable.

Individual contributor, reporting to the Director Clinical and Regulatory Affairs.