QA & Regulatory Affairs Specialist – Medical Devices

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

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.