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 Opportunity
* Be the strategic owner of QA & RA, from final submissions through post-market surveillance
* Act as Person Responsible for Regulatory Compliance (PRRC) under EU MDR
* Lead all interactions with Notified Bodies, FDA and global regulators
* Build, 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 readiness
* Manage and mentor a Senior Quality Engineer, while remaining deeply hands-on
This 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 For
* 10+ years' experience in Medical Device QA/RA (Class II / III experience strongly preferred)
* Proven track record with CE Marking, FDA 510(k) and regulatory inspections
* Strong working knowledge of EU MDR, ISO 13485, FDA 21 CFR Part 820
* Experience acting as a senior QA/RA leader in a start-up or scale-up environment
* Confident operating independently while developing others
* ISO 13485 Lead Auditor qualification
* Background in cardiovascular devices a strong advantage
Please apply with an up to date CV for consideration.