Excellent opportunity for a Regulatory Affairs Director to join a growing company in Galway. The Regulatory Affairs Director will oversee new product introductions with a global focus and the ideal candidate will have experience with New Product Development end to end.
Overview of your responsibilities (full job description available on request)
- Define global pathways, classification, and feasibility across supplements, cosmetics, U.S. Food and Drug Administration devices, EU MDR/CE, and water standards
- Own and deliver all regulatory submissions end-to-end, including authority interactions and timelines
- Set evidence strategy, oversee studies/CROs, and ensure claims are scientifically supported
- Govern claims and labeling, ensuring compliance and alignment with evidence
- Lead global registrations, monitor regulations, mitigate market risks, and support audits
Knowledge, Skills and Experience Required for the Role:
- Strong science/clinical background (advanced degree preferred)
- 10+ years’ regulatory experience across multiple product types
- Proven experience with:
- Dietary supplements and/or cosmetics (multi-market preferred)
- U.S. Food and Drug Administration device submissions (510(k)); EU MDR/CE Mark a plus
- Familiar with:
- ISO 9001:2015
- ISO 22716
- GMP CFR 111
- ISO 13485
- Led regulatory submissions end-to-end
- Direct interaction with regulatory authorities
- Able to balance compliance with business needs
For a confidential discussion and more information on the role contact Courtney Russell
courtney.russell@collinsmcnicholas.ie
+353 (0) 71 9108062
