Senior Manager, Regulatory Affairs

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hims & hers

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2017

⚕️ Healthcare Insurance

🛍️ eCommerce

🧘 Wellness

Healthcare Insurance • eCommerce • Wellness

Hims & Hers is an online platform with over 1 million subscribers that connects patients to licensed healthcare professionals across all 50 states in the U. S. The service offers comprehensive support for sexual health, weight loss, hair regrowth, mental health, and skincare through a 100% online process. Clients can receive personalized treatment plans which may include prescription medications, and benefit from free and discreet shipping. Hims & Hers prides itself on providing accessible and affordable healthcare without the need for insurance, offering transparent pricing and support from licensed providers. It aims to empower individuals by making healthcare and treatment conveniently available on their own terms, including mental health support, which includes treatments for anxiety and depression.

📋 Description

• 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. • 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

• 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