Director of Regulatory Affairs - Global NPD
About Your New Employer
- Join a pioneering company specializing in health, wellness, and innovative technologies, growing their portfolio globally.
- Work at the forefront of product innovation with a collaborative, cross-functional team influencing every stage of product development—concept to commercialization.
- Be part of a company renowned for market leadership, a diverse product range, and a strong focus on compliance and quality.
About Your New Job
As the Director of Regulatory Affairs - Global NPD, you will:
- Own the regulatory and clinical strategy for a global portfolio, including nutritional/dietary supplements, cosmetics, medical devices, and water technologies.
- Define and execute regulatory pathways (e.g., FDA, EU MDR/CE, global frameworks) for each product category, ensuring compliance from concept through to launch.
- Prepare and submit global regulatory dossiers; manage claims substantiation, clinical evidence planning, and the work of external regulatory consultants.
- Oversee all correspondence with regulatory authorities, coordinate responses, and maintain submission timelines to support successful commercialization.
- Establish claims and labeling standards, review artwork and packaging for compliance, and align marketing with defensible product claims.
- Lead 2-3 direct reports and external consultants, ensuring regulatory feasibility is embedded in business decision-making.
What Skills You Need
- Strong scientific or clinical background (advanced degree preferred).
- 10+ years’ regulatory experience across multiple product categories.
- Demonstrated experience with:
- Multi-market dietary supplement and/or cosmetic regulations.
- FDA device submissions (including 510(k)), EU MDR/CE Mark.
- Experience with ISO9001:2015, ISO22716, GMP CFR 111, ISO13485.
- Hands-on experience managing regulatory submissions and direct interface with authorities.
- Ability to work independently and as part of a global team, adapt to priorities, and thrive in a dynamic environment.
- Willingness to travel up to 10% internationally.
What's on Offer
- Competitive salary and comprehensive benefits package
- Opportunity to lead regulatory strategy on a global scale with innovative, market-leading products
- Development and progression as part of a results-driven and supportive international team
What's Next
Apply now by clicking the “Apply Now" button or call me, Alan Fitzpatrick, on +353 21 4847136. If the job isn’t quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC, and Contract jobs available.