RA/QA Officer

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 on your career.