Senior Specialist Medical Device

Fresenius Medical Care · Bengaluru

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.