Opportunity for a Quality Assurance and Regulatory Affairs Director to join a Galway Start-up.This is a rare opportunity to own QA/RA end-to-end at a company on the brink of commercialisation.Our client a Galway-based medical device start-up preparing for CE Marking and FDA 510(k) clearance in 2026, followed by global market launch is hiring a Quality Assurance and Regulatory Affairs Director.With a lean, high-calibre team and strong technical foundations, they are now seeking a senior, hands-on Director of QA/RA to lead them through this critical next phase.The OpportunityBe the strategic owner of QA & RA, from final submissions through post-market surveillanceAct as Person Responsible for Regulatory Compliance (PRRC) under EU MDRLead all interactions with Notified Bodies, FDA and global regulatorsBuild, embed and continuously improve a fit-for-purpose QMS (ISO 13485 / 21 CFR 820)Provide QA/RA leadership across design controls, risk management, supplier quality and manufacturing readinessManage and mentor a Senior Quality Engineer, while remaining deeply hands-onThis role suits someone who thrives in a small, fast-moving environment, is comfortable making decisions, and enjoys real ownership and visibility.What We're Looking For10+ years' experience in Medical Device QA/RA (Class II / III experience strongly preferred)Proven track record with CE Marking, FDA 510(k) and regulatory inspectionsStrong working knowledge of EU MDR, ISO 13485, FDA 21 CFR Part 820Experience acting as a senior QA/RA leader in a start-up or scale-up environmentConfident operating independently while developing othersISO 13485 Lead Auditor qualificationBackground in cardiovascular devices a strong advantagePlease apply with an up to date CV for consideration.