Regulatory Affairs Specialist
1 month ago
**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:
- Be the main contact for regulatory compliance issues.
- Lead and coordinate the vigilance process in interface with the complaint handling process.
- Liaise with regulatory authorities and external contract bodies and, in response to requests from these, collate and interpret specialised information.
- Interface with Competent Authorities for reporting incidents and field safety actions, including FSCA, FSN, recalls, MDRs (medical device reporting), BPDR (biological products deviation reports).
- Contribute to the regulatory watch process by maintaining knowledge of new or updated regulatory requirements, guidance documents, and industry standards.
Product Life Cycle Management:
- Liaise with regulatory authorities and external contract bodies and, in response to requests from these, collate and interpret specialised information.
- Ensure that changes are documented in accordance with quality system requirements and are communicated in a timely basis as appropriate to the Regulatory Authorities.
- 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.
- 1-4 years of experience in a regulatory/quality role.
- Experience in medical device / IVD / biotech industry.
- Specific technical competencies required for the role (e.g.: GMP, GLP exposure, FDA exposure, IT packages, technical writing skills).
- 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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