Senior Specialist Regulatory Affairs

Senior Regulatory Affairs role responsible for leading regulatory activities for medical devices and IVDs in the Europe, Middle East, Africa and Pakistan region; lead regulatory submissions, interact with EU Notified Bodies/UK Approved Body, maintain EU/UK Technical Files per MDR/IVDR, and mentor team members while implementing regulatory strategies and process improvements. Requires knowledge of MDR 2017/745, IVDR 2017/746, ISO13485, and experience with Notified Bodies and regulatory bodies; strong written and oral communication skills; Bachelor’s degree in a scientific discipline; location in Witney, United Kingdom; travel up to 5%.