Quality Assurance and Regulatory Affairs Specialist

Scienceabode; Corsham; On-site; GBP 37,000 - 43,000; Full time

Job summary

A medical device company in Corsham is seeking a Quality Assurance and Regulatory Affairs Specialist to ensure adherence to quality and regulatory standards. You will implement quality systems, monitor key performance indicators, and assist in regulatory submissions. The ideal candidate will have at least 4 years of relevant experience and a bachelor's degree. Competitive salary and benefits are offered.

Benefits

25 days holiday plus bank holidays

Company pension scheme

Qualifications

• 4+ years' experience in Quality Assurance or Regulatory Affairs in the medical device industry.
• Strong knowledge of EU MDR and IVDR regulations.

Responsibilities

• Implement and improve the Quality Management System.
• Monitor quality performance and KPIs.
• Support regulatory submissions and product registrations.

Skills

Quality Assurance

Regulatory Affairs

Analytical skills

Communication skills

Problem-solving

Education

Bachelor's degree in Biomedical Engineering or Life Sciences

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 & 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.

Qualifications

• 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: 20.12.2025. Please note this could change subject to suitable applications.