Senior Manager, Regulatory Affairs
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Job Description
Senior Manager of Regulatory Affairs seeking a candidate to manage FDA submissions and regulatory compliance. Join Hims & Hers in transforming healthcare with innovative solutions.
Responsibilities:
- Own the end-to-end lifecycle of FDA premarket applications
- Draft technical documentation, manage agency responses, and coordinate with Operational, Legal, and Clinical teams
- Operationalize and maintain compliance across diverse jurisdictions, including FDA and CMS
- Serve as the lead regulatory point of contact for agency audits and submissions
- Build and scale the "Technical Playbook" for medical product operations
Requirements:
- 12+ years in Regulatory Affairs, with an emphasis on the Medical Device industry and IVDs
- Proven "win record" with the FDA and have 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
- Advanced degree (Masters in Regulatory Affairs, PhD, or JD) or equivalent experience
- Thrive in high-growth environments requiring agile regulatory solutions
- Proactive self-starter who can operate autonomously with high-level direction
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
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