Senior Regulatory Affairs Specialist

Hybrid/Remote – must be able to travel to Warrington

Gi Group is proud to be partnering with a global leader in the life sciences sector, currently seeking a Senior Regulatory Affairs Specialist to join their EMEA Regulatory Affairs team on a 12-month contract.

This is an excellent opportunity for an experienced regulatory professional with a background in IVD or medical devices, looking to work in a dynamic, international environment. You will play a key role in supporting regulatory submissions and ensuring compliance for performance studies across the EU.

THE ROLE:

• Leading EU Member State notification activities for IVDR performance studies, particularly those involving leftover samples
• Preparing, reviewing, and submitting regulatory documentation to Competent Authorities and Ethics Committees
• Acting as the main point of contact for regulatory bodies, managing queries and requests for additional information
• ...

Ready to Apply?

Submit your application today and join our talented team at Gi Group.