Head of/Director, International Regulatory Affairs

Hims & Hers Health, Inc.

Job Overview

Location

London, England

Job Type

Full-time

Full Job Description

📋 Description

• Spearhead Hims & Hers’ first international regulatory affairs function outside the US, establishing the foundational strategy and infrastructure for global market expansion across the UK, EU, Canada, Australia, and Japan.
• Design and execute end-to-end regulatory roadmaps for market entry and product clearance, authoring and defending dossiers under UKCA/CE (MDR/IVDR), Health Canada submissions, TGA ARTG entries, and PMDA applications.
• Serve as the primary regulatory liaison to key international agencies including MHRA, EMA, Health Canada, TGA, and PMDA, leading pre-submission meetings and proactively anticipating regulatory developments impacting product strategy and market access.
• Own regulatory strategy for software-enabled and AI/ML products internationally, applying frameworks such as the EU AI Act, MHRA AI guidance, and IMDRF SaMD principles to digital health tools on the company’s platform.
• Partner strategically with international product, commercial, clinical, legal, and supply chain teams to embed regulatory diligence into early-stage business decisions, ensuring alignment between innovation and compliance.
• Build scalable regulatory processes, technical playbooks, and operational frameworks to support rapid international growth and future team expansion.
• Shape long-term international regulatory strategy in collaboration with the VP of Regulatory Affairs, translating corporate objectives into actionable regulatory pathways across diverse markets.
• Navigate multi-disciplinary regulatory landscapes spanning medical devices, IVDs, pharmaceuticals/compounding, telehealth, and consumer health products with fluency in EU MDR/IVDR, UKCA, and at least one additional major international framework.
• Drive commercial outcomes by positioning regulatory strategy as a growth enabler rather than a compliance constraint, influencing cross-functional teams to prioritize regulatory readiness in product development cycles.
• Operate with high autonomy and ambiguity, translating VP-level direction into independent execution without an established playbook, while maintaining rigorous standards for regulatory integrity and risk mitigation.
• Contribute to building a world-class global regulatory function by identifying talent needs, defining roles, and establishing culture and processes that scale with the company’s international revenue growth.
• Maintain up-to-date knowledge of evolving regulatory trends in digital health, AI-driven clinical tools, and consumer wellness products to ensure proactive and strategic positioning in new markets.
• Ensure all regulatory activities align with Hims & Hers’ mission to deliver affordable, accessible, and personalized health solutions while upholding ethical and compliance standards across jurisdictions.

🎯 Requirements

• 12+ years in Regulatory Affairs with proven track record of clearing products in two or more of: UK/EU, Canada, Australia, or Japan
• Hands-on dossier authoring experience for UKCA/CE (MDR/IVDR), Health Canada, TGA ARTG, and PMDA submissions
• Fluency in EU MDR/IVDR, UKCA, and at least one additional major international regulatory framework
• Deep understanding of AI/ML and SaMD regulatory frameworks including EU AI Act, MHRA AI guidance, and IMDRF SaMD principles
• Experience working across medical devices, pharmaceuticals/compounding, telehealth, and consumer health
• BSc or MSc in life sciences, pharmacy, biomedical engineering, or related field; RAC certification preferred

🏖️ Benefits

• Competitive salary & equity compensation for full-time roles
• Unlimited PTO, company holidays, and quarterly mental health days
• Offsite team retreats

Skills & Technologies

Junior

Remote

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Hims & Hers Health, Inc.

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About Hims & Hers Health, Inc.

Hims & Hers Health is a telehealth platform providing online consultations, prescription medications and over-the-counter wellness products for conditions such as hair loss, erectile dysfunction, anxiety, depression, skin care, and sexual health. Operating in the United States and select international markets, the company connects patients with licensed physicians and pharmacies, delivering treatments through subscription plans and direct-to-consumer shipping, while emphasizing privacy, affordability and accessibility.

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