Sr Manager, Regulatory Affairs
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.
Responsibilities
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.
Operationalize and maintain compliance across diverse and intersecting jurisdictions, including FDA (Device, Drug & Compounding) and CMS (CLIA/CAP).
Serve as the lead regulatory point of contact relating to federal and state agency audits, inspections, or submission inquiries.
Build and scale the "Technical Playbook" for our medical product operations, ensuring the company stays ahead of shifting state, federal, and international regulations.
Requirements
12+ years in Regulatory Affairs, with an emphasis on the Medical Device industry and IVDs. Experience with pharmacy compounding is a plus.
You have a proven "win record" with the FDA and have personally authored multiple successful 510(k) clearances, specifically IVDs.
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.
Qualifications
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.
Skills
Strong understanding of FDA regulations and processes.
Experience with IVDs and compounding pharmacy.
Excellent communication and collaboration skills.
Benefits
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.