Program Management - Program Manager V

Interim Chief Healthcare Compliance Officer & Associate General Counsel (Compliance)

Duration:

6

Months Location:

Remote Role Overview We are seeking a senior healthcare compliance leader and digital health attorney to serve as an interim Chief Healthcare Compliance Officer and Associate General Counsel (Compliance). The role is responsible for leading a global healthcare compliance program and providing legal and regulatory guidance for digital health initiatives, including AI-enabled health products, wearables, and medical device-related technologies. This position sits within the Corporate Compliance & Ethics function and plays a critical leadership role in ensuring healthcare-related business activities comply with applicable federal and international regulations. Key Responsibilities 1. Healthcare Compliance Program Leadership Lead and manage the organization's Healthcare Compliance Program Oversee compliance policies, procedures, audits, training, and risk assessments Ensure program effectiveness and continuous improvement Report compliance risks and program status to senior leadership and board-level stakeholders 2. Compliance Governance & Committee Leadership Chair the Healthcare Compliance Committee Schedule and lead governance meetings Develop agendas, documentation, and committee charters Advise on committee structure, membership, and escalation processes 3. Healthcare Regulatory Legal Advisory Provide legal guidance on healthcare fraud and abuse laws, including: Anti-Kickback Statute (AKS) Stark Law False Claims Act (FCA) Advise on federal healthcare program compliance requirements Review and approve healthcare-related business arrangements 4. FDA & Digital Health Regulatory Support Advise on FDA medical device regulations, including: 510(k) De Novo classification Software as a Medical Device (SaMD) Support regulatory strategy for digital health and health technology products Provide guidance on international medical device regulations (e.g., EU MDR) 5. Product & Business Enablement Partner with product, engineering, legal, and business teams Provide compliance guidance for health-related product launches Ensure global scalability of healthcare compliance frameworks Enable compliant commercialization of health technologies 6. Investigations & Risk Management Support internal investigations into compliance issues Design and implement corrective action plans Identify and escalate compliance risks Ensure documentation of compliance concerns and resolutions 7. Training & Communication Develop and deliver compliance training programs Maintain internal compliance communication channels Respond to employee compliance inquiries Required Qualifications Juris Doctor (J.D.) degree required Active Bar membership (licensed attorney) 10-15+ years of legal and healthcare compliance experience 7-10+ years focused specifically on healthcare regulatory/compliance work Strong expertise in: Healthcare fraud & abuse laws (AKS, Stark Law, FCA) Federal healthcare program compliance Experience building and managing compliance programs (policies, audits, training, reporting) Prior in-house or health-tech/medical industry experience preferred Preferred Qualifications FDA medical device regulatory experience (510(k), De Novo, SaMD) Experience in digital health, medtech, or healthcare technology International regulatory exposure (EU MDR or equivalent) Experience chairing governance or compliance committees Experience supporting compliance program effectiveness assessments (e.g., DOJ guidance) Experience with investigations and remediation plans Experience Level 10-15+ years of combined legal and healthcare compliance experience Senior leadership-level compliance or legal role (Director / Senior Director / VP equivalent) Key Performance Expectations Maintain uninterrupted healthcare compliance program operations Ensure timely governance meetings, audits, and reporting deliverables Provide accurate, actionable legal and compliance guidance to business teams Identify and mitigate regulatory risks proactively Support board-level reporting and executive communications Maintain high-quality documentation and compliance tracking