Director of Regulatory Affairs

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