Reference Number: JO-2410-542356
Regulatory Affairs Officer – Post Market
Rate: Negotiable
Job Type: Contract
Location: Edinburgh
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:
1. Be the main contact for regulatory compliance issues
2. Provide PMS documentation according to IVDR requirements (PMS Plan, SSP, PMS Report, PSUR)
3. Lead and coordinate the vigilance process in interface with the complaint handling process
4. Liaise with regulatory authorities and external contract bodies and, in response to requests from these, collate and interpret specialised information.
5. Interface with Competent Authorities for reporting incidents and field safety actions, including FSCA, FSN, recalls, MDRs (medical device reporting), BPDR (biological products deviation reports)
6. Contribute to the regulatory watch process by maintaining knowledge of new or update 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.
Requirements:
1. A degree or equivalent in life sciences.
2. 1-4 years of experience in a regulatory/quality role.
3. Experience in medical device / IVD / biotech industry
4. Experienced in meeting with, making presentations to, and negotiating with regulators.
5. Specific technical competencies required for the role (e.g.: GMP, GLP exposure, FDA exposure, IT packages, technical writing skills)
6. 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..).
7. 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.
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