VP, Regulated Device Engineering

About the role

The VP, Regulated Device Engineering is responsible for the overall leadership, strategy, and execution of the company's regulated medical device business organization. This role owns end-to-end product development, from concept through commercialization, ensuring compliance with all FDA and global regulatory requirements while driving innovation, quality, and operational excellence. This leader will directly oversee Research & Development and have cross-functional influence with Quality, Regulatory Affairs, Clinical, and Manufacturing to ensure successful product development, approval, and market adoption. Business & Strategic Leadership Define and execute the strategic roadmap for the regulated devices portfolio, aligned with company growth objectives Own budgeting, and resource allocation for the regulated devices business unit - Partner with executive leadership to identify new product opportunities - Build and scale a high-performing, cross-functional organization Product Development & R&D Leadership Directly lead R&D developing regulated medical devices from concept through design transfer and commercialization Ensure design control processes are robust, compliant, and efficiently executed (21 CFR Part 820, ISO 13485) Drive innovation while maintaining disciplined product development processes, including risk management (ISO 14971) and usability engineering Quality & Regulatory Oversight Ensure all products meet FDA, international regulatory, and quality system requirements Partner closely with Quality and Regulatory leaders to support successful submissions (e.g., 510(k), De Novo as applicable) Champion a culture of quality and compliance across the organization - Ensure inspection readiness and successful audits (FDA, notified bodies, etc.) Cross-Functional Leadership Provide indirect leadership and alignment across Clinical, Manufacturing, and Supply Chain Ensure clinical strategies support regulatory and commercial objectives Collaborate with Manufacturing/Operations to ensure scalable, cost-effective, and compliant production processes Operational Excellence Establish and monitor KPIs across development, quality, regulatory, and manufacturing readiness Drive continuous improvement in product development lifecycle, time-to-market, and cost efficiency Identify and mitigate technical, regulatory, and operational risks You Have: Bachelor's degree in Mechanical Engineering 15+ years of experience in the medical device industry, with significant experience in Class II devices Proven leadership experience overseeing R&D teams and product development pipelines Deep knowledge of FDA regulations, including 21 CFR Part 820, and international standards such as ISO 13485 and ISO 14971 Demonstrated success leading products through regulatory clearance (e.g., 510(k)) and commercialization Experience working closely with Quality and Regulatory functions in a design controlled environment 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 Comprehensive health benefits including medical, dental & vision, and parental leave Employee Stock Purchase Program (ESPP) 401k benefits with employer matching contribution Offsite team retreats We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply-even if you're not sure if your background or experience is a perfect match. 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 t

Benefits

Additional Information

Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we're making better health outcomes easier to achieve. Hims & Hers is a public company, traded on the NYSE under the ticker symbol "HIMS." To learn more about the brand and offerings, you can visit hims.com/about and hims.com/how-it-works . For information on the company's outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals .

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