hims-and-hers - Head of/Director, International Regulatory Affairs
Requirements
• 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 • Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws. • It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. • Hims & Hers is committed to providing reasonable accommodations for qualified individuals with disabilities and disabled veterans in our job application procedures. If you need assistance or an accommodation due to a disability, please contact us at [email protected] and describe the needed accommodation. Your privacy is important to us, and any information you share will only be used for the legitimate purpose of considering your request for accommodation. Hims & Hers gives consideration to all qualified applicants without regard to any protected status, including disability. Please do not send resumes to this email address. • To learn more about how we collect, use, retain, and disclose Personal Information, please visit our Global Candidate Privacy Statement https://www.hims.com/global-candidate-privacy-statement.
Responsibilities
• 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.
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