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