Senior Product Counsel

Responsibilities 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 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, 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 Licensed to practice law #J-18808-Ljbffr