Regulatory Affairs Officer

Cpl Life Sciences – Edinburgh, City of Edinburgh

Job Type: 12-Month Fixed-Term Contract

Location: Outskirts of Edinburgh, Scotland, UK – 3x a week on site but could consider a remote profile.

The role is a full-time, permanent position working 37.5 hours per week.

The purpose of the role is for implementing and maintaining regulatory compliance processes including regulatory evaluation of non-conformances, post market surveillance, vigilance and associated reporting, regulatory and standard watch. The role is responsible for coordinating the HHE activities that may be required based on individual non-conformances or product complaints.

Responsibilities will include:

• Be the main contact for regulatory compliance issues
• Provide PMS documentation according to IVDR requirements (PMS Plan, SSP, PMS Report, PSUR)
• 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 manner 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.

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.
• 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.).
• Specialist knowledge of vigilance processes for US, EU and other jurisdictions as appropriate (MDR, MEDDEV 2.12, etc.).