Quality Assurance and Regulatory Affairs Specialist

Quality Assurance and Regulatory Affairs Specialist

Tip Top Job  is looking for a Quality Assurance and Regulatory Affairs Specialist to help ensure our medical device products meet the highest standards of safety and performance.

Location:

Corsham, Wiltshire

Hours:

Monday to Friday, 8:30 am – 5:00 pm
Salary:
Negotiable (approx £37,000)
Holidays: 25 days plus bank holidays
Benefits:
Company pension scheme

You will support the Quality and Regulatory team in maintaining compliance with medical device and IVD standards and regulations. You will monitor and advise on the performance of the Quality Management System (QMS), produce reports on key indicators, and drive continuous improvement initiatives across the organisation.

• Implement, maintain, and improve the Quality Management System in line with applicable standards and regulations.
• Monitor and report on quality performance, including tracking key performance indicators (KPIs).
• Contribute to regulatory submissions, technical documentation, and product registrations.
• Provide guidance on compliance with EU MDR, IVDR, and other international regulations.
• Support internal and external audits and ensure timely resolution of findings.
• Drive problem‑solving and continuous improvement initiatives across departments.

• Bachelor’s degree in a relevant discipline (e.g., Biomedical Engineering, Life Sciences, Regulatory Affairs).
• Minimum of 4 years experience in Quality Assurance or Regulatory Affairs within the medical device industry.
• Strong knowledge of domestic and international medical device standards and regulations, including EU MDR and IVDR.
• Excellent written and verbal communication skills.
• Strong analytical, problem‑solving, and critical thinking abilities.
• High attention to detail and organisational skills.
• Ability to collaborate effectively within cross‑functional teams.

Closing date: 06.02.2026. Please note this could change subject to suitable applications.