QARA Officer

A growing medical device manufacturer and distributor in Bristol Area is looking to add a Quality and Regulatory Officer to their UK team, supporting manufacturing, distribution, new product development and international markets. This is a hands-on role covering ISO 13485 quality systems and global regulatory compliance, ideal for someone who enjoys owning processes end-to-end and working closely with operations, suppliers and regulatory bodies. What you ll be doing: Maintaining and improving the ISO 13485 / ISO 9001 Quality Management System Ensuring compliance with UKCA, EU MDR, FDA 21 CFR Part 820 and other global regulations Managing Notified Body and Competent Authority audits (surveillance and recertification) Leading complaints, CAPAs, vigilance, FSCA/FSN and non-conformance investigations Owning technical files, risk management files and DHF/DMR documentation Supporting post-market surveillance and clinical evaluation activities Reviewing and approving labelling, IFUs, artwork and promotional materials Supporting supplier quality, audits and risk reviews Providing QARA input into new product development and change control Supporting product registrations across UK, EU and ROW markets What we re looking for: Experience in Quality and Regulatory roles within medical devices Strong knowledge of ISO 13485 and medical device regulations Confidence working with technical files, risk management and audits Comfortable operating in a manufacturing and distribution ..... full job details .....