Regulatory Affairs Specialist

3 weeks ago


Edinburgh, Edinburgh, United Kingdom Cpl Life Sciences Full time £50,000

Job Title:

Quality and Compliance Regulatory Affairs

Job Type:

Permanent position

Edinburgh (Hybrid, 3x a week in the office)

Compliance and Regulatory Affairs Specialist responsible for delivering end-to-end regulatory packages under ODM-Distributor schemes in compliance with established quality management systems.

Key responsibilities include:

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

Maintain product and site regulatory and quality compliance to ensure license/registration is maintained. Provide training and guidance to other regulatory and quality affairs team members as needed.

Key Skills:

  • Regulatory affairs management
  • Quality management system implementation
  • Medical device compliance
  • In vitro diagnostic expertise

Applicants must have a Master's degree or equivalent in life sciences and 3-5 years of experience in a regulatory or quality role.

Requirements:

  • Right to work in the UK
  • Ability to work in the office 3x a week


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