Regulatory Affairs Director

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

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