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.
