Senior Product and Regulatory Counsel (Medtech)

TL;DR

Senior Product and Regulatory Counsel (Medtech): Serving as a lead strategic advisor at the intersection of consumer wellness technology and regulated digital health products with an accent on FDA/MDR compliance and SaMD features. Focus on guiding cross-functional teams through the development, validation, and commercialization of regulated health innovations and AI-driven features.

Location: Remote within the United States. Candidates cannot be based in Alaska, Delaware, Iowa, Mississippi, Missouri, Nebraska, South Dakota, West Virginia, or Wisconsin. Hybrid options available in San Francisco, San Diego, and Los Angeles.

Salary: $117,300 - $169,000 (depending on region)

Company

hirify.global develops award-winning wellness technology, including the hirify.global Ring, to help people understand and improve their health through daily insights.

What you will do

• Serve as primary legal advisor on medical device regulatory requirements and support FDA submissions and global filings.
• Partner with Product, Science, and Engineering teams from ideation to ensure features meet global standards.
• Establish scalable product development governance frameworks integrating regulatory, privacy, and clinical requirements.
• Advise on legal and regulatory considerations for AI-enabled and algorithm-driven health features.
• Provide guidance on clinical validation strategies, including study design and research partnerships.
• Review promotional materials and marketing claims for compliance with consumer protection and regulatory laws.

Requirements

• Juris Doctor (J.D.) degree and an active license to practice law in the United States.
• 8+ years of relevant legal experience.
• Deep understanding of U.S. medical device regulations (FDA, SaMD, clinical evaluation).
• Familiarity with international frameworks including EU MDR and ISO standards.
• Must be based in the US (excluding specific restricted states).
• Ability to translate complex legal requirements into actionable advice for non-legal stakeholders.

Nice to have

• Experience with wearable technology, connected health products, or consumer health platforms.
• Familiarity with the EU AI Act and FDA guidance on AI/ML in medical devices.
• Prior in-house experience at the FDA or within a medtech/digital health company.
• Experience advising on clinical studies for regulated products.

Culture & Benefits

• Competitive salary and equity packages.
• Comprehensive health, dental, vision insurance, and mental health resources.
• Complimentary hirify.global Ring and employee discounts for friends and family.
• Generous time off: 20 days PTO, 13 paid holidays, and 8 flexible wellness days.
• Paid sick leave and parental leave.