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Jobs/Regulatory Affairs Specialist Role/openloophealth - Regulatory Counsel, Healthcare
openloophealth

openloophealth - Regulatory Counsel, Healthcare

Remote - United States1mo ago
RemoteStaffNADigital HealthTelemedicineRegulatory Affairs SpecialistLegal CounselDigital MarketingRecords ManagementE-commerce

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Requirements

• J.D. from an accredited law school and active bar membership in at least one U.S. jurisdiction (with ability to register as in-house counsel where required). • Minimum of 10 years of healthcare law experience, with a substantial focus on healthcare marketing, advertising, and promotional regulatory matters. • Deep working knowledge of FDA promotional regulations, FTC advertising standards, HIPAA, and state consumer protection and healthcare advertising laws. • Demonstrated experience reviewing and approving DTC healthcare marketing at volume, across digital channels. • Excellent judgment and the ability to translate complex regulatory frameworks into clear, practical guidance for non-lawyers. • Strong written and verbal communication skills and a track record of operating independently in a fast-moving environment. • Prior in-house experience at a telehealth, digital health, or DTC healthcare company — strongly preferred. • Experience advising on GLP-1s / obesity medications, hormone therapies (TRT, menopause, thyroid), or longevity and wellness products, including compounded formulations. • Familiarity with the MSO / friendly-PC model and the corporate practice of medicine doctrine across multiple states. • Experience with performance marketing workflows, ad-tech and pixel privacy issues, and AI-enabled marketing tools. • Track record managing NAD challenges, FTC inquiries, or state AG investigations.

Responsibilities

• Serve as the primary legal partner for growth and creative teams, reviewing digital ads, landing pages, and influencer content to ensure compliance with FTC and platform standards. • Provide expert counsel on FDA rules for prescription and compounded medications, claims substantiation, and state-level "Anti-Kickback" and consumer protection laws. • Build scalable review workflows and self-serve guardrails that allow marketing teams to move quickly without manual legal bottlenecks. • Counsel on HIPAA, patient consent, and the use of tracking technologies (pixels) within healthcare e-commerce and acquisition funnels. • Draft and negotiate specialized agreements for influencers, marketing agencies, and pharmacy partners, specifically focusing on compounded medication and cash-pay models.

Benefits

• In addition, for salaried positions you would also be eligible for: • Medical, Dental, and Vision plans • Flexible Spending/Health Savings Accounts • 401(k) + Company Match • Life Insurance, Pet insurance, and more • We have a relatively flat organizational structure here at OpenLoop. Everyone is encouraged to bring ideas to the table and make things happen. This fits in well with our core values of Autonomy, Competence and Belonging, as we want everyone to feel empowered and supported to do their best work. • Sound like a good fit? We’d love to meet you.

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