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OpenLoop is a telehealth platform enabling care delivery across all 50 states. As Senior Director of Compliance & Regulatory Affairs, you will own end-to-end accountability for the company's compliance program and regulatory readiness across multi-state telehealth operations.
You will report to the VP of Compliance and Healthcare, serve as the named responsible executive in regulator-facing documentation, and directly manage a team including the Healthcare Investigations Manager, Policy & Governance Manager, Exclusion & Sanction Screening Lead, and HIPAA & Privacy Compliance Manager.
Key responsibilities include: designing and maintaining all seven OIG compliance elements as a documented program; owning the policy and SOP lifecycle across subsidiaries with mapping to OIG, FDA, GDPR, and CMS controls; managing HIPAA Privacy and Security programs including breach response; overseeing the ethics hotline and investigation program; establishing FDA quality-system and promotional controls for regulated devices and SaMD components; personally holding OIG Element 3 to design compliance training curriculum and set cultural tone; managing exclusion/sanction screening and conflict-of-interest programs; and preparing board-level reporting on program status and risk posture.
You bring 12+ years of healthcare compliance, regulatory affairs, or health law experience with demonstrated end-to-end compliance program ownership. You have deep knowledge of the OIG Seven Elements framework, HIPAA Privacy and Security program ownership, and ideally GDPR experience. FDA regulatory experience with devices, SaMD, or digital health is a strong plus. You've managed and developed compliance teams in multi-state, technology-forward healthcare environments and are familiar with telehealth regulatory landscapes including multi-state practice authority and prescribing rules. A compliance credential (CHC, CHPC, CCEP) is preferred. You have executive presence, sound judgment, high integrity, and can influence across Legal, Product, Security, and Clinical functions.
