Regulatory Affairs Specialist

1 month ago


Edinburgh, Edinburgh, United Kingdom Clinical Professionals Limited Full time

**Job Title:** Regulatory Affairs Specialist

**Job Type:** Contract

**Location:** Edinburgh

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Clinical Professionals Limited. As a key member of our regulatory team, you will be responsible for implementing and maintaining regulatory compliance processes, including regulatory evaluation of non-conformances, post-market surveillance, vigilance, and associated reporting.

Key Responsibilities:

  1. Be the main contact for regulatory compliance issues.
  2. Lead and coordinate the vigilance process in interface with the complaint handling process.
  3. Liaise with regulatory authorities and external contract bodies and, in response to requests from these, collate and interpret specialised information.
  4. Interface with Competent Authorities for reporting incidents and field safety actions, including FSCA, FSN, recalls, MDRs (medical device reporting), BPDR (biological products deviation reports).
  5. Contribute to the regulatory watch process by maintaining knowledge of new or updated regulatory requirements, guidance documents, and industry standards.

Product Life Cycle Management:

  1. Liaise with regulatory authorities and external contract bodies and, in response to requests from these, collate and interpret specialised information.
  2. Ensure that changes are documented in accordance with quality system requirements and are communicated in a timely basis as appropriate to the Regulatory Authorities.
  3. Assist with the implementation of the Company's Quality Policy to ensure compliance with Good Manufacturing Practice (cGMP), 13485 standards, the 98/79/EC IVD Directive, IVD 2017/746 Regulation, FDA Regulations, Health Canada Medical Device Regulation, Part 1, Good Clinical Practice (GCP) and approved Health and Safety Policies.
  4. 1-4 years of experience in a regulatory/quality role.
  5. Experience in medical device / IVD / biotech industry.
  6. Specific technical competencies required for the role (e.g.: GMP, GLP exposure, FDA exposure, IT packages, technical writing skills).
  7. Significant specialist knowledge of regulation as applied to medical devices, in vitro diagnostic medical devices, or Biologics (93/42/EC, 98/79/EC directives, 510(k), PMA, CMDR, etc.).


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