Regulatory Affairs Specialist

Duties:

• Under guidance, update technical documentation files to align with EU MDR medical device requirements
• Submit Regulatory Impact Assessments to countries using Veeva system and ensure completeness of assessment from countries
• Coordinate submission package and manage country timelines to support approval of lifecycle management changes for medical devices
• Under guidance, collect data from Technical Documentation File in preparation for Eudamed go-live
• Verify registration data in Veeva database for US and Canada medical devices

Qualification:

• Bachelor's Degree preferably in biomedical fields
• Expertise in MDR (Medical Device Regulation)
• Experience in medical device regulatory compliance