Hims & Hers
Head of/Director, International Regulatory Affairs
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We are Hims & Hers, the leading health and wellness platform, dedicated to empowering the world to feel great through better health. As a public company (NYSE: “HIMS”), we revolutionise healthcare by prioritising the customer and delivering affordable, accessible, and personalised care—from diagnosis to treatment to delivery. Our mission is to make better health outcomes achievable by normalising wellness challenges and innovating their solutions.
We’re seeking a dynamic Head of/Director of International Regulatory Affairs to spearhead our global regulatory function, establishing us as an industry leader across telehealth, pharmaceuticals, medical devices, SaMD, AI-driven clinical tools, and consumer health.
About the Role
Reporting directly to the VP of Regulatory Affairs, this pivotal role demands a strategic thinker to drive our international regulatory posture, supporting global market expansion, product launches, and growth in markets like the UK, EU, Canada, Australia, and Japan. You’ll shape regulatory approaches, ensure compliance, and build a scalable international regulatory function—a rare opportunity to establish groundbreaking frameworks for a fast-growing global health company.
Key Responsibilities
Market Access & Dossier Authoring
- Design and execute regulatory roadmaps for targeted market entry in UKCA/CE (MDR/IVDR), Health Canada, TGA (ARTG), and PMDA.
- Author and defend end-to-end submissions across international regulatory frameworks.
Strategic Cross-Functional Collaboration
- Partner closely with international product, commercial, clinical, legal, and supply chain leaders to embed regulatory vigilance in critical business decisions.
- Align stakeholders on regulatory requirements for market entry, product strategy, and growth initiatives.
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Emerging Technologies & Compliance
- Lead SaMD, AI, and digital health regulatory strategy, leveraging frameworks like the EU AI Act, MHRA AI guidance, and IMDRF SaMD principles.
- Translate complex regulatory finer points into actionable strategies that support product innovation.
Regulatory Agency Representation
- Serve as the primary liaison with regulatory bodies (MHRA, EMA, Health Canada, TGA, PMDA).
- Proactively engage in pre-submission discussions and anticipate changes that influence strategy and growth plans.
Functional Expansion & Team Leadership
- Establish processes, playbooks, and frameworks to scale the international regulatory function.
- Shape long-term regulatory strategy with the VP of Regulatory Affairs, and assist in infrastructure development for global expansion.
Requirements
Experience & Expertise
- 12+ years in Regulatory Affairs, with demonstrated success in two or more regions: UK/EU (MDR/IVDR), Canada, Australia, or Japan.
- Hands-on experience authoring compliance dossiers and navigating market authorisation schemes.
Regulatory Breadth & Specialisation
- Fluency in regulatory landscapes for medical devices/IVDs, SaMD, AI, telehealth, pharmaceuticals, and consumer health.
- Deep understanding of AI/ML and digital health regulations, including:
- EU AI Act,
- MHRA AI guidance,
- IMDRF SaMD frameworks.
Leadership & Strategic Mindset
- Agency-builder mentality: Thrives with ambiguity, leverages autonomy, and transforms strategic direction (VP/Vice President level) into autonomous execution.
- Commercially minded: Views regulatory strategy as a core growth lever, not merely a compliance obligation.
- Exceptional stakeholder influence: Bridges gaps between regulatory, product, legal, and clinical teams in agile, high-pressure environments.
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Education & Certification
- BSc or MSc in:
- Life sciences,
- Pharmacy,
- Biomedical engineering, or a related field.
- Postgraduate qualification or RAC (Registration/Associate Certification) in Regulatory Affairs preferred.
Why Join Hims & Hers?
Join a forward-thinking, mission-driven company where ambition is celebrated, and wellness is democratised. Our culture emphasises flexible work arrangements, a talent-first approach, and inclusivity—with extraordinary benefits across the board.
Highlights
✔ Competitive salary and equity (for full-time roles) ✔ Unlimited Paid Time Off plus company holidays and quarterly mental health days ✔ Offsite team retreats ✔ Holistic support for growth through innovation
About Us
Diversity, fairness, and accessibility are at the heart of our values. We embrace candidates with diverse backgrounds and acknowledge the importance of opportunities for all—a transformative approach to building teams that drive impact.
Applying
Apply now. There’s no perfect resume—just the right one.
Promissional Inquiries
Hims & Hers adheres to:
- San Francisco Fair Chance Ordinance
- Los Angeles County Fair Chance Ordinance
- California’s Fair Chance Act
- And similar regulations globally.
Disability accommodations? Contact accommodations@forhims.com for support.
Full Global Candidate Privacy Statement available at [promo site]. Hims & Hers welcomes applications from individuals of all backgrounds.
For full-time opportunities, equitable opportunities abound.
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