Vp, U.s. Regulatory Affairs (Medtech)

TL;DR

VP, U.S. Regulatory Affairs (Medtech): Leading the company's regulatory strategy, filings, and regulatory intelligence in the U.S. market with an accent on digital health, telemedicine, pharmacy, consumer health, AI, and emerging care categories. Focus on managing regulator-facing submissions, anticipating regulatory risks and opportunities, and equipping cross-functional partners with regulatory insights.

Location: US Remote. Based in the US.

Salary: $300,000 – $360,000

Company

hirify.global is the leading health and wellness platform, on a mission to help the world feel great through the power of better health.

What you will do

• Lead the development of the company’s U.S. regulatory strategy for digital health, telemedicine, pharmacy, and consumer products.
• Oversee all regulatory filings, submissions, and registrations, including FDA establishment registrations and product listings.
• Provide regulatory intelligence by monitoring federal and other regulatory activity and synthesizing developments into actionable insights.
• Advise various teams on regulatory expectations related to product development, market entry, claims, labeling, and operational requirements.
• Draft and manage regulatory collateral, including submission packages, responses to regulator inquiries, and internal regulatory guidance documents.
• Serve as a regulatory representative in external interactions with regulators, consultants, standards bodies, or working groups.

Requirements

• Bachelor’s degree required; advanced degree preferred (JD, PharmD, MPP, MPH, MS Regulatory Affairs, or related).
• 15+ years of experience in regulatory affairs, health policy, healthcare compliance, life sciences, digital health, or related sectors.
• Experience working with FDA-regulated products or compliance frameworks, or experience within a U.S. healthcare regulatory agency or comparable regulatory environment required.
• Demonstrated experience preparing or managing regulatory submissions, licensing activities, or regulatory documentation.
• Strong understanding of FDA regulatory pathways, OTC and consumer health regulation, telehealth/telemedicine oversight, pharmacy regulations, and digital health policy environments.
• Exceptional writing, analytical, and communication skills.

Culture & 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