SrManager,RegulatoryAffairs

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 http://hims.com/about and hims.com/how-it-works http://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 http://www.hims.com/careers-professionals. ABOUT THE ROLE: Hims & Hers is evolving into a complex healthcare entity that blends digital health, compounding, and medical technologies. To support this evolution, we are seeking a Senior Manager of Regulatory Affairs. This is a high-impact role designed for a "Swiss Army Knife" of regulatory execution. You will be the primary technical lead responsible for translating product innovations into successful regulatory filings, and bridging the gap between legal requirements and regulatory execution across our entire ecosystem.   YOU WILL: - Premarket Strategy & Execution: Own the end-to-end lifecycle of FDA premarket applications, with an immediate focus on authoring and steering 510(k) submissions to clearance. This includes drafting technical documentation, managing agency responses, and coordinating with Operational, Legal, and Clinical teams. - Ecosystem Compliance: Operationalize and maintain compliance across diverse and intersecting jurisdictions, including FDA (Device, Drug & Compounding)