Serve as a strategic legal partner to the company’s Product, R&D, Hardware, Marketing, and Clinical teams
Advise on the full spectrum of legal and regulatory issues that arise as the company scales innovative digital health products and services
Own FDA and medical device legal work and manage the legal work related to FDA-cleared medical devices
Coordinate with international outside counsel to advise on legal requirements across multiple countries
Review marketing materials for compliance with FDA promotional requirements and other guidelines
Proactively identify legal and regulatory issues in company initiatives
Create and maintain legal resources, guidance documents, and trainings

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, with a strong preference for product counsel experience in the digital health, health tech, or medical device space
Demonstrated expertise in FDA regulations and medical device requirements (e.g., 510(k) process, device modifications, promotional compliance)
Experience using AI tools to enhance and accelerate deliverables
Experience advising on international product launches and navigating multi-jurisdictional regulatory frameworks (e.g., EU MDR/IVDR, UK medical device regulations, Health Canada)
Familiarity with government contracting requirements (FAR, FEHBAR, TAA) and programs such as Medicare, Medicaid, VA, and TRICARE
In-house experience at a technology or digital health company, combined with law firm experience at a nationally recognized firm
Strong track record of cross-functional collaboration and ability to communicate complex legal and regulatory concepts in a clear, business-friendly manner
Self-starter who thrives working independently; comfortable with ambiguity and shifting priorities

Senior Product Counsel

Key skills