Senior Specialist Medical Device
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About the role
Fresenius Medical Care operates in the medical device industry. This specialist will manage global regulatory documentation, approvals, registrations and regulatory changes across product development and commercialization.
What you'll do
- Manage technical files, registration dossiers, instructions for use and labeling
- Ensure regulatory compliance and testing requirements during product development
- Coordinate approvals and change notifications with authorities and Notified Bodies
- Manage registrations, renewals and submissions to support product availability
- Coordinate regulatory product strategies
- Lead regulatory documentation for product and process changes
Skills
Must have
- Medical device regulatory affairs
- Regulatory submissions
- Regulatory compliance
- Technical documentation
Who it's for
- Domain
- medical devices
About Fresenius Medical Care
Fresenius Medical Care has 35 open roles in Bangalore, at Fresenius Medical Care Global Business Services (GBS) Bangalore. See every Fresenius Medical Care role.
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