Hims & Hers is a public company that is seeking a Senior Manager of Regulatory Affairs to support its evolution into a complex healthcare entity. The role will be responsible for translating product innovations into successful regulatory filings and bridging the gap between legal requirements and regulatory execution across the company's ecosystem.
Requirements
- 12+ years of experience in Regulatory Affairs, with an emphasis on the Medical Device industry and IVDs
- Experience with pharmacy compounding is a plus
- Proven "win record" with the FDA and personally authored multiple successful 510(k) clearances, specifically IVDs
- Deep, hands-on experience navigating the "four corners" of health regulation: FDA, DEA, CMS/CLIA, and FTC
- International regulatory experience is a plus
- Advanced degree (Masters in Regulatory Affairs, PhD, or JD) or equivalent experience
Benefits
- Competitive salary & equity compensation
- 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