Fresenius Medical Care Healthcare/BioTech

Senior Specialist Medical Device

Bengaluru, India In person Full-time
  • Location: Bengaluru, KA
  • 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.

Job description provided by Fresenius Medical Care.
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