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.
Show more Show less