Regulatory Affairs Director/Senior Manager

2 weeks ago


Gloucester, Gloucestershire, United Kingdom CV-Library Full time

Selexa Biotech is seeking a highly experienced Senior Regulatory Affairs Leader to join their team. The ideal candidate will have a strong background in Medical Device Regulatory Affairs and a proven track record of delivering robust RA processes.

The successful candidate will be responsible for leading a team of Regulatory Affairs Specialists and contributing to regulatory strategies for new products and design changes to existing products.

Key responsibilities will include:

  • Creating, updating, and maintaining technical files in support of product updates and maintaining Notified Body CE Certification, FDA clearance, and UKCA marking.
  • Interpreting standard, regulatory, and customer requirements for implementation in the QMS.
  • Completing internal audits as assigned.

Candidate requirements include:

  • 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 understanding of Quality Management Systems.


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