Senior Product Counsel

Responsibilities include:

Enable product and business initiatives. Collaborate with Product, R&D, Engineering, Marketing, Hardware, Clinical, and other stakeholders throughout the organization to understand, advise on, and drive forward new products, services, technologies, and processes impacting the company’s business and members. Serve as a trusted, business-enabling legal partner from brainstorm through launch.
Own FDA and medical device legal work. Advise the hardware and product teams on FDA regulatory requirements, including 510(k)/de novo submissions, new indications, device modifications, clinical research, and regulatory inquiries. Manage the legal work related to the company’s FDA-cleared medical devices and help avoid enforcement actions.
Advise on global expansion. Coordinate with international outside counsel to advise on legal and regulatory requirements across multiple countries and territories. Identify barriers to international product launches, develop creative compliance solutions, and own the global legal workstream for the Product Legal team.
Provide guidance on healthcare regulatory and government programs. Advise on legal frameworks applicable to government programs (e.g., Medicare, VA, TRICARE), first dollar coverage (FDC) eligibility, CARES Act implications, and government contracting issues.
Support marketing and commercial claims. Review marketing materials, claims, and messaging for legal and regulatory compliance, including FDA promotional requirements, FTC guidelines, and truth-in-advertising standards.
Protect the company from unnecessary risk. Proactively identify legal and regulatory issues in company initiatives, think creatively to develop solutions, and collaborate cross-functionally to help the business move forward while managing risk.
Develop resources and generate efficiencies. Create and maintain legal resources, guidance documents, FAQs, and trainings to aid internal teams in developing and launching products and services. 
Stay ahead of the regulatory landscape. Keep up-to-date on legal and regulatory developments relevant to digital health, medical devices, and provision of care and ensure key stakeholders are promptly advised on potential risks and opportunities.

Experience includes:

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 and comfort with working at both an operational and strategic level.
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