Regulatory Affairs Officer – Post Market

Regulatory Affairs Officer – Post Market

Job description

Overview

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 update 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 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.)

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▶️ Regulatory Affairs Officer – Post Market
🖊️ Cpl Life Sciences
📍 Edinburgh