About this role
Senior Specialist Medical Device
- Manage global regulatory product documentation, including technical files, registration dossiers, IFUs, and labeling
- Ensure compliance with regulatory standards and testing requirements throughout product design and development
- Coordinate regulatory approvals and change notifications with Notified Bodies and Authorities
- Ensure global regulatory product availability aligned with commercial strategy by managing registrations, renewals, and submissions
- Coordinate regulatory product strategies
- Lead regulatory aspects of product and process changes, including regulatory documentation.