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Senior Specialist Medical Device @ Freseniusmedicalcare

Bengaluru, KAOnsiteFull-time
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About this 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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