Cpl Life Sciences
Regulatory Affairs Officer
Job Location
Job Description
Job Title: Regulatory Affairs Officer – Post-Market Surveillance
Job Type: 12-Month Fixed-Term Contract
Location: Outskirts of Edinburgh, Scotland, UK – 3x a week on site but could consider a remote profile.
Remuneration: £37,000 - £40,000 + benefits
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 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.
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.)
For more information please reach out to lucy.kirkaldy@cpl.com please note that you MUST have the full right to work in the UK and be able to be office based 3x a week.
Location: Edinburgh, GB
Posted Date: 10/28/2024
Contact Information
Contact | Human Resources Cpl Life Sciences |
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