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Senior Specialist Medical Device

Fresenius Medical Care

Bengaluru, KA, IndiaFull-timePosted 1w agoStill listed 1 day ago

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At a glance

Compensation
No compensation found
Location
Bengaluru, KA, India
Schedule
Full-time
Work Authorization
Not specified

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Job overview

The Senior Specialist will manage global regulatory product documentation, ensure compliance with standards throughout design and development, coordinate approvals and change notifications with notified bodies, and align product availability with commercial strategy through registrations, renewals, and submissions.

Skills & qualifications

RequiredNice to have

Skills

Regulatory DocumentationTechnical FilesRegistration DossiersIFUsLabelingComplianceRegulatory StandardsTesting RequirementsProduct DesignProduct DevelopmentRegulatory ApprovalsChange NotificationsNotified BodiesRegulatory AuthoritiesRegistrationsRenewalsSubmissionsProduct StrategyProcess Changes

Full job description

  • 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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