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RA/QA Specialist

Job details
Posting date: 27 February 2025
Hours: Full time
Closing date: 29 March 2025
Location: Uxbridge, London, UB8 2DB
Company: Hays Specialist Recruitment
Job type: Permanent
Job reference: 4663624_1740671974

Summary

Your new company
Our clients are a growing medical device company specialising in product development, commercialisation, manufacturing, sales and distribution. The product range includes IV therapy, diabetes care, surgical, anaesthesia, sexual health, cosmetics, etc. With a strong presence across the UK and Europe, they are committed to delivering high-quality, innovative healthcare solutions that improve patient outcomes.
Your new role
You will support with all quality assurance and regulatory affairs activities - ensuring the company's policies are implemented as part of normal processes across the company.

You will be involved in:

  • Liaising with stakeholders to ensure they maintain compliance with the company's policies and procedures.
  • Supporting company's Quality Management System (QMS)
  • Compliance with UKCA, EU MDR, FDA
  • Writing, reviewing, and maintaining technical files as well as other relevant regulatory documentation (e.g. MDD, UKCA, MDR, IVDR, Procedure pack)
  • Product development
  • Keep up with relevant regulations or (ISO) standards updates
  • Ensuring that the business is working towards a smooth MDR implementation/transition process.
  • Coordinate both internal and external audits.
  • Ensuring compliance is always kept to the highest standard.
  • Document control - updating quality procedure documents and product fact sheets to make sure they are accurate.

What you'll need to succeed

  • Experience within the medical device field, all classes of medical devices
  • Good general knowledge of ISO13485 is preferable.
  • Relevant science-based degree
  • Logical thinking and proactive approach to problem-solving.
  • Good interpersonal skills.
  • Excellent report writing skills with a strong attention to detail.
  • Good organisational and time management skills, with the ability to prioritise and handle a complex, varied workload.
  • Office software: Microsoft, Adobe, etc.
  • Multi-language skill is an extra

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.