Senior Director, Compliance & Regulatory Affairs
New
J
JobgetherHealthcare Technology
Based in the United StatesFull-TimeDirector
Salary not disclosed
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Job Details
- Experience
- 12+ years
- Required Skills
- HIPAARisk Management
Requirements
- 12+ years of progressive experience in healthcare compliance, regulatory affairs, health law, or a related field.
- Extensive knowledge of the OIG Seven Elements of an Effective Compliance Program.
- Strong expertise in HIPAA Privacy and Security regulations.
- Experience supporting FDA regulatory compliance for medical devices, SaMD, or digital health solutions.
- Demonstrated leadership experience managing compliance professionals in multi-state healthcare or technology-enabled organizations.
- Solid understanding of telehealth regulations, including multi-state practice and prescribing requirements.
- Professional compliance certification such as CHC, CHPC, or CCEP is preferred.
- GDPR knowledge is considered a strong advantage.
- Exceptional leadership, communication, analytical, and decision-making skills.
Responsibilities
- Lead and oversee the organization's enterprise-wide compliance program, ensuring alignment with the Office of Inspector General (OIG) Seven Elements framework.
- Develop, implement, and manage compliance policies, governance frameworks, standard operating procedures, and documentation.
- Direct HIPAA Privacy and Security initiatives, oversee data protection and breach response, and support GDPR compliance.
- Manage ethics, investigations, hotline operations, corrective action plans, and conflict-of-interest programs.
- Oversee regulatory affairs related to FDA requirements, digital health technologies, and medical devices.
- Design and maintain organization-wide compliance education and training programs.
- Lead and mentor a multidisciplinary compliance team and provide executive and board-level reporting.
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