Regulatory Affairs Director/Senior Manager

2 weeks ago


Cheltenham, Gloucestershire, United Kingdom Selexa Consulting Ltd Full time

Selexa Consulting Ltd is seeking an experienced Regulatory Affairs Director/Senior Manager to lead their Medical Device manufacturer client's regulatory affairs team.

The ideal candidate will have a strong background in regulatory affairs, with experience in managing teams and developing robust RA processes.

Key responsibilities include:

  • Leading the creation, updating, and maintenance of technical files in support of product updates and maintaining Notified Body CE Certification, FDA clearance, and UKCA marking.
  • Contributing to regulatory strategies for new products and design changes to existing products.
  • Assisting in the interpretation of standard, regulatory, and customer requirements for implementation in the QMS.
  • Completing internal audits as assigned.

Candidate Requirements & Experience:

  • A degree or relevant experience in Medical Devices, Engineering, or associated Scientific discipline.
  • A minimum of 7-10 years experience within Medical Device Regulatory Affairs.
  • A strong and practical experience and understanding of Quality Management Systems.


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