Senior Specialist Medical Device

Job description

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.