QA / RA Officer

SRG; United Kingdom; On-site; GBP 40,000 - 50,000; Full time

Job summary

A leading company in medical devices based in Liverpool is seeking a proactive Quality & Regulatory Affairs Officer. The successful candidate will maintain QMS documentation, conduct internal audits, and ensure compliance with UK and international regulations. Ideal applicants will have a Bachelor's degree and 2-3 years' experience in Quality Assurance or Regulatory Affairs within the medical devices sector. Exceptional communication and technical writing skills are required for this full-time role.

Qualifications

• 2-3 years' experience in Quality Assurance or Regulatory Affairs within medical devices.
• Strong knowledge of ISO 13485, UK MDR, and EU MDR.
• Experience with internal audits in a quality management context.

Responsibilities

• Maintain and control QMS documentation in line with ISO 13485:2016.
• Conduct internal audits and support CAPA/NCR investigations.
• Assist in supplier qualification and audits.

Skills

Quality Assurance

Regulatory Affairs

Internal Auditing

Technical Writing

Communication Skills

Education

Bachelor's degree in a scientific, engineering, or life science discipline

Job description

Quality & Regulatory Affairs Officer

Location: Liverpool, UK
Employment Type: Full-Time, Permanent
Department: Quality & Regulatory Affairs (QARA)

About the Role

We are seeking a proactive Quality & Regulatory Affairs Officer to join a growing team. In this dual-function role, you will support the ongoing compliance of their Quality Management System (QMS) and contribute to Regulatory Affairs (RA) activities ensuring our medical device products meet all UK and international regulatory standards.
This is an exciting opportunity for someone with solid QA/RA experience in the medical device industry who is looking to develop their expertise in a fast‑paced, compliance‑driven environment.

Key Responsibilities

• Maintain and control QMS documentation in line with ISO 13485:2016.
• Conduct internal audits and support CAPA/NCR investigations and closure.
• Assist in supplier qualification, audits, and quality agreements.
• Prepare and maintain Technical Files and regulatory documentation.
• Support UKCA and CE marking activities.
• Liaise with MHRA, Notified Bodies and other global authorities.
• Manage Post‑Market Surveillance, including complaint handling and vigilance reporting.
• Monitor changes to relevant medical device regulations and standards.

About You

Essential:

• Bachelor's degree in a scientific, engineering, or life science discipline.
• 2-3 years' experience in Quality Assurance or Regulatory Affairs within medical devices.
• Strong knowledge of ISO 13485, UK MDR, and EU MDR (2017/745).
• Internal auditing experience.
• Excellent communication, documentation control, and technical writing skills.

Desirable:

• Experience with MDR transition audits and interacting with Notified Bodies.
• Understanding of risk management (ISO 14971) and biocompatibility (ISO 10993).
• Familiarity with eQMS platforms.
• Professional memberships (TOPRA, RAPS, CQI, ASQ).

Guidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio are acting as an Employment Business in relation to this vacancy