Senior Specialist Medical Device
Fresenius Medical Care
- Location
- Bengaluru, Karnataka, India
- Job type
- Full-time
About the role
Fresenius Medical Care
Website:
freseniusmedicalcare.com
Job details:
- 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.
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