Senior Specialist Medical Device

Fresenius Medical Care · Bengaluru, IN

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• 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...