Senior Director, Compliance & Regulatory Affairs
Accountabilities: Lead and oversee the organization's enterprise-wide compliance program, ensuring alignment with the Office of Inspector General (OIG) Seven Elements framework and maintaining regulatory readiness across applicable healthcare regulations.
Develop, implement, and manage compliance policies, governance frameworks, standard operating procedures, and documentation throughout their lifecycle.
Direct HIPAA Privacy and Security initiatives, oversee data protection and breach response processes, and support GDPR compliance requirements where applicable.
Manage ethics, investigations, hotline operations, corrective action plans, conflict-of-interest programs, exclusion and sanction screening, and regulatory reporting.
Oversee regulatory affairs related to FDA requirements, digital health technologies, medical devices, and healthcare compliance obligations, while monitoring evolving regulatory changes.
Design and maintain organization-wide compliance education and training programs, promoting a proactive culture of compliance across employees and clinical partners.
Lead and mentor a multidisciplinary compliance team, provide executive and board-level reporting, and collaborate with Legal, Product, Security, Clinical, and operational stakeholders to strengthen governance and risk management.
Requirements
12+ years of progressive experience in healthcare compliance, regulatory affairs, health law, or a related field, with direct ownership of enterprise compliance programs.
Extensive knowledge of the OIG Seven Elements of an Effective Compliance Program and experience implementing comprehensive compliance frameworks.
Strong expertise in HIPAA Privacy and Security regulations, with GDPR knowledge considered a strong advantage.
Experience supporting FDA regulatory compliance for medical devices, Software as a Medical Device (SaMD), digital health solutions, or related healthcare technologies is highly desirable.
Demonstrated leadership experience managing compliance professionals within complex, multi-state healthcare, telehealth, or technology-enabled healthcare organizations.
Solid understanding of telehealth regulations, including multi-state practice requirements and prescribing regulations.
Professional compliance certification such as CHC, CHPC, CCEP, or an equivalent credential is preferred.
Exceptional leadership, communication, analytical, and decision-making skills, with the ability to influence senior stakeholders and represent the organization in regulator-facing activities.
High ethical standards, sound judgment, and a collaborative leadership style capable of building strong cross-functional partnerships.
Benefits
Comprehensive medical, dental, and vision insurance.
Flexible Spending Account (FSA) and Health Savings Account (HSA) options.
Flexible paid time off.
401(k) retirement plan with company matching contributions.
Life insurance coverage.
Pet insurance.
Additional employee wellness and benefit programs.
Opportunity to work within a collaborative organization that encourages autonomy, innovation, and professional growth.
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