Regulatory Affairs Officer

3 weeks ago


Edinburgh Scotland, Scotland, United Kingdom SRG Full time

Title: Regulatory Affairs Officer

Location: Edinburgh area – hybrid working

Type: Full-time, Permanent, 37.5 hours per week.

Salary: up to £37,000 DOE

SRG is working with a leading Biotechnology company based in the Edinburgh area who are looking for a Regulatory affairs officer to join their team on a permanent basis.

The regulatory affairs officer will be involved in building a regulatory strategy, determining applicable regulatory requirements, proposing solutions to comply with regulatory requirements and managing product license registration with the appropriate regulatory authorities worldwide.

Requirements:

  • Scientific degree
  • Previous regulatory experience within Medical Devices / IVD
  • Experience of working within an FDA licensed manufacturing facility.
  • Knowledge and practical experience of CE and FDA regulations, including the preparation of PMA, BLA, 510k, CE Mark and technical file submissions.
  • Change control experience

Benefits:

  • Private Medical cover
  • Life assurance
  • Additional annual leave
  • Cycle to work scheme + more.

If you would like to apply for this position, please use the link provided. Alternatively please email a copy of your CV



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