Regulatory Affairs Expert

**Regulatory Affairs Expert (Medical Devices)**

**Your responsibilities:**

+ 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.

Your profile:

+ Master’s degree in Technical, Engineering, or Scientific fields
+ Minimum of 8-10 years in Regulatory Affairs or Quality Assurance in Medical Devices or Medicinal Products
+ Knowledge of development and manufacturing processes
+ Familiarity with qua...

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Submit your application today and join our talented team at Fresenius Medical Care.

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