Sr Manager, Regulatory Affairs

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.

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) and CMS (CLIA/CAP).
• Agency Liaison: Serve as the lead regulatory point of contact relating to federal and state agency audits, inspections, or submission inquiries.
• The Regulatory "Playbook": Build and scale the "Technical Playbook" for our medical product operations, ensuring the company stays ahead of shifting state, federal, and international regulations.

You Have

• Experience: 12+ years in Regulatory Affairs, with an emphasis on the Medical Device industry and IVDs. Experience with pharmacy compounding is a plus.
• The Submission Expert: You have a proven "win record" with the FDA and have personally authored multiple successful 510(k) clearances, specifically IVDs.
• Regulatory Polymath: You have deep, hands-on experience navigating the "four corners" of health regulation: FDA, DEA, CMS/CLIA, and FTC. International regulatory experience is a plus.
• Education: Advanced degree (Masters in Regulatory Affairs, PhD, or JD) or equivalent experience.
• Adaptability: You thrive in high-growth environments where the product roadmap pivots quickly and requires agile regulatory solutions.
• Self-Starter and Autonomy: You are a proactive self-starter who can operate autonomously with high-level direction, adept at identifying and driving regulatory needs without constant oversight.