Regulatory Affairs Expert

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
+ Drive regulatory assessments for product and process changes, including software updates, patches, cloud‑infrastructure changes
+ 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
+ Knowled...