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
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
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