Head of/Director, International Regulatory Affairs

About the Role: As Head of/Director of International Regulatory Affairs, you will be the company's first regulatory anchor outside the US — spearheading our international regulatory posture across telehealth, pharmaceuticals/compounding, medical devices, SaMD, AI‑driven clinical tools, and consumer health. You will report directly to the VP of Regulatory Affairs, operate as a strategic partner to international commercial and product teams, and build the foundation for a world‑class global regulatory function. This is a unique opportunity to be the first dedicated Regulatory Affairs leader for one of the most‑watched consumer health companies in the world and to shape regulatory approaches. As Hims & Hers continues its international expansion, this role will help ensure regulatory strategy enables speed, innovation, and sustainable growth across global markets.

You Will:

• Market Entry & Clearance: Design and execute regulatory roadmaps that enable market expansion, new product launches, and category growth across the UK, EU, Canada, Australia, and Japan. Author and defend dossiers end‑to‑end: UKCA/CE under MDR/IVDR, Health Canada submissions, TGA ARTG entries, and PMDA applications.
• Cross‑Functional Partnership: Serve as a strategic regulatory partner to international product, commercial, clinical, legal, and supply chain leaders, ensuring regulatory considerations and diligence are integrated into business decisions early and effectively.
• SaMD, AI & Emerging Frameworks: Own regulatory strategy for software‑enabled and AI/ML products internationally -- including EU AI Act obligations, MHRA AI guidance, and IMDRF SaMD frameworks as applied to our digital health platform.
• Agency Engagement: Serve as the official liaison to MHRA, EMA, Health Canada, TGA, and PMDA. Lead pre‑submission meetings and anticipate regulatory developments that could impact product strategy, market access, and growth plans.
• Function Building & Strategy: Establish the foundational processes, technical playbooks, and regulatory frameworks that allow the international business to scale. Shape the long‑term international regulatory strategy alongside the VP, and assist in building the infrastructure and team to support it as global revenue grows.

You Have:

• Experience: 12+ years in Regulatory Affairs with a proven track record of clearing products in two or more of the following: UK/EU, Canada, Australia, or Japan. Hands‑on dossier authoring required.
• Multi‑Disciplinary Regulatory Background: Genuine breadth across medical devices/IVDs, SaMD/AI, pharmaceuticals/compounding, telehealth, and consumer health. Fluency in EU MDR/IVDR, UKCA, and at least one additional major international regulatory framework.
• AI & Digital Health Fluency: A deep understanding of emerging AI and digital health regulatory frameworks, including the EU AI Act, MHRA AI guidance, and IMDRF SaMD principles, with the ability to translate evolving requirements into practical regulatory strategies to support product and business priorities.
• High‑Agency Builder Mentality: A track record of thriving with ambiguity and autonomy. The ability to translate VP‑level direction into independent execution without an established playbook. A commercially minded approach -- seeing regulatory strategy as a market entry lever, not just a compliance function. Exceptional ability to influence and align stakeholders across product, clinical, legal, quality, and commercial teams in a fast‑moving environment.
• Education: A BSc or MSc in life sciences, pharmacy, biomedical engineering, or a related field; a postgraduate qualification in Regulatory Affairs is preferred. An advanced degree is a plus. RAC or equivalent professional certification is valued.

Our Benefits (there are more but here are some highlights): Competitive salary & equity compensation for full‑time roles, Unlimited PTO, company holidays, and quarterly mental health days, Offsite team retreats.