Regulatory Affairs Specialist

4 weeks ago


Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full time £50,000
Job Title: Quality & Regulatory Affairs Specialist

Job Type: Permanent position

Location: Outskirts of Edinburgh (Hybrid, 3x a week in the office)

An exciting opportunity to join an established and growing IVD manufacturer and support a growing Regulatory Affairs Department.

The Quality & Regulatory Affairs Specialist is responsible for delivering end-to-end regulatory packages under ODM-Distributor schemes in compliance with established quality management systems.

Key Responsibilities:

  • Initial compilation of design control evidence
  • Supplier management
  • Incoming inspection and product release process
  • Product submission
  • Post-market surveillance
  • Vigilance and associated reporting

The role is responsible for maintaining product and site regulatory & quality compliance to maintain license/registration once granted.

Key Requirements:

  • Master's degree or equivalent in life sciences
  • 3-5 years of experience in a regulatory/quality role
  • Experience in the medical device / IVD / biotech industry
  • Significant specialist knowledge of regulation as applied to medical devices, in vitro diagnostic medical devices, or Biologics

Please note that you MUST have the full right to work in the UK and be able to be office-based 3x a week.



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