Senior Manager, Regulatory Affairs

hims & hers

Senior Manager, Regulatory Affairs leading FDA submissions and compliance for healthcare innovations. Overseeing regulatory execution and documentation for the evolving health and wellness platform at Hims & Hers.

Posted 6/22/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $170,000 - $200,000 per yearWebsite

About the role

Key responsibilities & impact

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

What you’ll need

12+ years 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 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. International regulatory experience is a plus.
Advanced degree (Masters in Regulatory Affairs, PhD, or JD) or equivalent experience.
Thrive in high-growth environments where the product roadmap pivots quickly and requires agile regulatory solutions.
Proactive self-starter who can operate autonomously with high-level direction, adept at identifying and driving regulatory needs without constant oversight.

Benefits

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

FDA premarket applications510(k) submissionstechnical documentationregulatory complianceauditsinspectionsregulatory affairsmedical device industryIVDspharmacy compounding

Soft Skills

proactiveself-starterautonomoushigh-level directionagile solutionscommunicationleadershiporganizational skillscollaborationproblem-solving

Certifications

Masters in Regulatory AffairsPhDJD