Quality Assurance & Regulatory Affairs Specialist

TipTopJob; Corsham; On-site; GBP 37,000; Full time

Job summary

A medical device company in Corsham seeks a Quality Assurance and Regulatory Affairs Specialist to ensure compliance with industry standards. The ideal candidate will have a relevant degree and a minimum of 4 years experience in Quality Assurance or Regulatory Affairs. Responsibilities include maintaining the Quality Management System, monitoring performance metrics, and supporting regulatory submissions. This role offers a competitive salary and benefits including 25 days of holiday plus bank holidays.

Benefits

25 days holiday plus bank holidays

Company pension scheme

Qualifications

• Minimum of 4 years experience in Quality Assurance or Regulatory Affairs in the medical device industry.
• Strong knowledge of EU MDR, IVDR, and other international regulations.

Responsibilities

• Implement and improve the Quality Management System in line with applicable standards.
• Monitor and report on quality performance and KPIs.
• Contribute to regulatory submissions and technical documentation.
• Support internal and external audits and resolve findings.

Skills

Strong analytical skills

Excellent written and verbal communication

Problem-solving abilities

High attention to detail

Organisational skills

Education

Bachelor’s degree in Biomedical Engineering, Life Sciences, or Regulatory Affairs

Job description

Job Title: Quality Assurance and Regulatory Affairs Specialist

Location: Corsham, Wiltshire

Hours of Work: Monday to Friday, 8.30am to 5pm

Salary: Negotiable: circa £37,000 depending on experience

Holiday and Benefits: 25 days plus bank holidays, company pension scheme.

Are you passionate about quality, compliance, and making a real impact in the medical device industry? We’re looking for a Quality Assurance and Regulatory Affairs Specialist to join our team and help ensure that our products meet the highest standards of safety and performance.

This is an exciting opportunity to work in a dynamic environment where innovation and quality are at the heart of everything we do. You’ll play a key role in ensuring compliance and driving improvements that make a difference worldwide.

About The Role

In this role, you’ll support the Quality and Regulatory team in maintaining compliance with medical device and IVD standards and regulations. You’ll 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.

Key Responsibilities

• 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.

What We’re Looking For

• 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 is 06.02.2026. Please note this could change subject to suitable applications.

Hawk 3 Talent Solutions are acting as an employment agency on behalf of its client.

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