Job Description

Head of Regulatory Affairs, NY | $160,000 – $180,000 base salary, plus benefits

A leading international consumer health and wellness company is seeking a strategic and experienced Head of Regulatory Affairs to lead global regulatory strategy and compliance across a diverse and high-growth product portfolio.

This critical leadership role will oversee the classification, registration, and market access of products across multiple jurisdictions, spanning medical devices, cosmetics, and wellness categories. The successful candidate will partner cross-functionally to support innovation, ensure compliance, and maintain brand integrity in a complex, evolving regulatory landscape.

What You’ll Do:

• Lead global regulatory strategy and execution across all product categories and markets
• Manage regulatory submissions and approvals (e.g. FDA, EU MDR, TGA, ANVISA, SFDA)
• Support compliant product claims, packaging, and marketing content
• Guide regulatory pathways for new product launches and market expansions
• Collaborate with R&D, Marketing, Legal, and Quality teams to drive compliant innovation
• Represent the company in audits, inspections, and agency communications
• Monitor regulatory trends and translate them into business impact and strategy
• Lead and develop a high-performing global regulatory team

What We’re Looking For:

• 10+ years’ experience in regulatory affairs within consumer health, medical devices, or wellness
• Deep knowledge of international regulatory frameworks (FDA 510(k), CE Mark, ISO 13485, cosmetics regulation)
• Proven leadership skills, including managing global teams and engaging with regulators
• Strong cross-functional communication and influencing capabilities
• Experience in regulated product claims, ethical marketing, and online sales channels preferred
• Regulatory Affairs Certification (RAC) or advanced degree is a plus

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