Fresenius Medical Care India
Senior Specialist Medical Device
- Location Bengaluru, KA
- Experience ~5-10 yrs
- Job type Full-time
- Posted 9 Oct 2026
You will be taken to the employer’s own careers page to apply.
Job details
- Job ID
- R0260458
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.