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Posted 29 days ago · Fresenius Medical Care · Bengaluru, KA

Senior Specialist Medical Device

The role

* 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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