Job Title

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, FDAWriting, reviewing, and maintaining technical files as well as other relevant regulatory documentation (e.g. MDD, UKCA, MDR, IVDR, Procedure pack)Product developmentKeep up with relevant regulations or (ISO) standards updatesEnsuring 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 devicesGood general knowledge of ISO13485 is preferable.Relevant science-based degreeLogical 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 extraWhat 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.