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About the Role

Serve as a strategic legal partner to Product, R&D, Hardware, Marketing, and Clinical teams, advising on legal and regulatory issues for innovative digital health products and services, including an FDA-cleared device and AI-driven care platform. This high-impact role requires an experienced attorney to navigate complex legal landscapes and drive business initiatives.

Responsibilities

• Enable product and business initiatives by collaborating with cross-functional teams from brainstorm through launch.
• Own FDA and medical device legal work, advising on regulatory requirements and managing legal aspects of cleared devices.
• Advise on global expansion by coordinating with international counsel and developing compliance solutions.
• Provide guidance on healthcare regulatory and government programs, including Medicare, VA, and TRICARE.
• Support marketing and commercial claims by reviewing materials for legal and regulatory compliance.
• Proactively identify and mitigate legal and regulatory risks in company initiatives.
• Develop resources, guidance documents, and trainings to support internal teams.
• Stay updated on legal and regulatory developments in digital health and medical devices.

Requirements

• J.D. from an ABA-accredited law school.
• Licensed to practice law in at least one U.S. jurisdiction.
• 5-7 years of experience advising on healthcare legal and regulatory matters.
• Strong preference for product counsel experience in digital health, health tech, or medical device space.
• Demonstrated expertise in FDA regulations and medical device requirements.
• Experience using AI tools to enhance and accelerate deliverables.
• Experience working at both an operational and strategic level.
• Experience advising on international product launches and navigating multi-jurisdictional regulatory frameworks.
• Familiarity with government contracting requirements and programs.
• In-house experience at a technology or digital health company, combined with law firm experience.
• Strong track record of cross-functional collaboration.
• Ability to communicate complex legal and regulatory concepts clearly and in a business-friendly manner.
• Self-starter who thrives working independently and is comfortable with ambiguity and shifting priorities.

Skills

• Product Counsel
• Digital Health
• Health Tech
• Medical Device
• FDA Regulations
• AI Tools
• International Regulatory Frameworks
• Government Contracting
• Cross-functional Collaboration
• Legal & Regulatory Compliance

Location

• Remote

Work Type

• Full-time

Experience Level

• Senior

Education Level

• J.D.

Salary/Compensations

• $216,000 – $324,000

Benefits

• Retirement plans with company match
• Modern life stipends
• Support for family and wellness needs
• Equity participation

About the Company

• A publicly traded digital health company leveraging technology and AI to transform care delivery.