SeniorProductCounsel

## 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