Sr Manager, Regulatory Affairs
Role Overview
The Senior Manager of Regulatory Affairs at Hims & Hers leads FDA premarket submissions, including authoring 510(k) filings for IVDs, and ensures compliance across FDA, DEA, CMS/CLIA, and FTC regulations. This senior-level role involves acting as the primary regulatory liaison during agency audits and building scalable compliance playbooks for a fast-paced digital health ecosystem. The hire will drive regulatory strategy for medical devices, compounding, and digital health products, directly impacting product launches and market access.
Perks & Benefits
This is a fully remote role with a flexible work approach, offering unlimited PTO, quarterly mental health days, and comprehensive health benefits including medical, dental, and vision. The company provides competitive salary, equity compensation, an Employee Stock Purchase Program, and 401k with employer matching. Career growth is supported in a high-growth environment where regulatory innovation is valued, and team offsite retreats are included.
Full Job Description
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.
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 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 accommodations@forhims.com 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.
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