Location: Sunbury-on-Thames (on-site / commutable distance required)
Industry: Medical Devices
Are you highly organised, detail-driven, and looking to build or grow your career in Quality Assurance and Regulatory Affairs within the medical devices space?
We’re partnering with a well-established and innovative organisation operating at the forefront of laboratory and healthcare technology. With a strong international presence and a reputation for quality and precision, this company plays a key role in supporting advancements in areas such as research, cell therapy, and fertility.
They are now looking to hire a QARA Administrator to support their Quality and Regulatory teams in maintaining compliance and driving operational excellence.
The Role
This is a fantastic opportunity to gain hands-on experience across both QA and RA in a regulated environment. You’ll play a central role in maintaining quality systems, supporting regulatory submissions, and ensuring the business continues to meet global compliance standards.
Key Responsibilities
Quality Assurance
1. Maintain and support the Quality Management System (QMS) in line with ISO 13485 and internal procedures
2. Manage document control processes, ensuring accuracy and timely updates
3. Support CAPA, non-conformances, complaints, and change control activities
4. Assist with internal and external audits (including regulatory bodies and suppliers)
5. Ensure training records are complete and up to date
6. Monitor calibration schedules, equipment maintenance, and environmental controls
Regulatory Affairs
7. Assist in preparing documentation for regulatory submissions
8. Support product registrations across global markets (including UK and EU)
9. Track and monitor regulatory changes, identifying potential compliance gaps
About You
10. Bachelor’s degree in a relevant field Quality, Engineering, Life Sciences)
11. Experience in a regulated environment (medical devices or pharma preferred)
12. Familiarity with ISO 13485, EU MDR, and/or FDA regulations is advantageous
13. Strong organisational and administrative skills
14. Excellent attention to detail
15. Confident using MS Office tools (Word, Excel, Outlook, Teams)
Additional Requirements
16. Must have the right to work in the UK (no sponsorship available)
17. Able to commute to site regularly
18. Willingness to undergo background checks for trusted positions
What’s on Offer
19. 25 days annual leave + bank holidays
20. Opportunity to work in a growing, purpose-driven organisation
21. Exposure to global regulatory frameworks and quality systems
22. A collaborative and supportive team environment