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Job Information

Regulatory Affairs Senior Specialist

Information About this Role

A fantastic opportunity for an experienced RA Specialist to play a pivotal role for a product area within an international market leader in Medical Devices.

You will be joining a team of 4 (extended team of 10) at a time of innovation and product development.

If you have established experience in the requirements and registrations for European class III devices with additional knowledge of 510ks and PMAs this is a great opportunity!

Job Title: Regulatory Affairs Senior Specialist

Reporting to: Regulatory Affairs Manager

Salary: £45-55K, negotiable plus an impressive range of benefits.

Contract: Permanent, Full Time

This is a comprehensive role is responsible for ensuring that regulatory submissions are appropriately developed from start to finish for approval and clearance of products.

The Compile and Manage Regulatory submissions which can cover but are not limited to:

  • Class III design dossiers, preparation of technical files for class I, IIa, IIb (EU).
  • Premarket Approval Applications (PMAs) and Supplements, Investigational Device Exemptions (IDEs), and Premarket Notifications (510(k)s).
  • Ensures regulatory interface throughout the entire product life cycle including post-market surveillance.
  • Hands-on in Competent Authority interaction.
  • Review and approve all Engineering Change Requests (ECRs).

Regulatory Affairs Senior Specialist

  • A minimum of 3 years' experience in Regulatory Affairs.
  • Degree educated.

If this sounds like the role for you then do not hesitate! APPLY NOW!

If you have any further questions regarding this role please call James Powell: 02038000509.

Projectus Consulting

Projectus Consulting are a leading Medical Device Recruitment Consultancy. We are a niche business providing a highly specialist service to both employers and candidates within Medical Technology spaces.

We are passionate about finding the right role for you.