QARA Officer

A growing medical device manufacturer & distributor in Bristol Area is looking to add a Quality & 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 & 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 & 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 environment * Ability to work cross-functionally with operations, suppliers and management * Degree in Engineering, Life Sciences or equivalent experience preferred If you’re a hands-on QARA professional looking for a role with real ownership and exposure across the full product lifecycle, this one’s worth a conversation