Regulatory Affairs Specialist

4 weeks ago


Greater Edinburgh Area, United Kingdom Cpl Life Sciences Full time

**Job Title:** Regulatory Affairs Specialist

**Job Type:** Full-time

**Location:** Flexible

**Remuneration:** Competitive salary + benefits

The Regulatory Affairs Specialist will be responsible for implementing and maintaining regulatory compliance processes, including regulatory evaluation of non-conformances, post-market surveillance, vigilance, and associated reporting. The role will also involve coordinating HHE activities and liaising with regulatory authorities and external contract bodies.

**Key Responsibilities:**

  • Be the main contact for regulatory compliance issues
  • Provide PMS documentation according to IVDR requirements
  • Lead and coordinate the vigilance process
  • Liaise with regulatory authorities and external contract bodies
  • Interface with Competent Authorities for reporting incidents and field safety actions

**Requirements:**

  • A degree or equivalent in life sciences
  • 1-4 years of experience in a regulatory/quality role
  • Experience in the medical device / IVD / biotech industry
  • Experienced in meeting with, making presentations to, and negotiating with regulators

**About Cpl Life Sciences:**

Cpl Life Sciences is a leading provider of recruitment services to the life sciences industry. We are committed to helping our clients find the best talent to drive their business forward.



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