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Your new companyOur 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 roleYou 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 nowIf 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.
