Regulatory Compliance Director

Regulatory Compliance Director

The Regulatory Compliance Director is a key part of the Compliance team, collaborating across all areas of the organization with a focus on creating a culture of trust and ethical conduct and promoting detection and prevention of conduct that does not align with DFCI's ethical standards, federal and state healthcare laws, payer requirements and internal policies. The Regulatory Compliance Director is responsible for developing, implementing, and overseeing a comprehensive regulatory compliance program across the Institute. This role ensures that all operations, including clinical, research, and administrative functions, adhere to federal, state, and local regulatory requirements. The Director collaborates with multidisciplinary teams to assess regulatory risks, develop and update policies and procedures, and manage and maintain continuous readiness and compliance. The Regulatory Compliance Director will report directly to the Chief Compliance Officer.

Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS, and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.

Primary Duties and Responsibilities

Regulatory Compliance

• Provide subject matter expertise on federal, state, and local regulatory requirements (e.g., CMS compliance, Stark and Anti-Kickback laws, physician compensation). Provide expert compliance guidance to leadership, staff, and stakeholders.
• Monitor changes in regulatory requirements, assess their impact on organizational practices, and provide actionable compliance guidance to stakeholders to ensure adherence.

Policy and Procedure Development

• Oversee the development, maintenance, and communication of compliance-related policies and procedures to ensure they are up-to-date and aligned with current laws, regulations, and best practices. Revise and adapt organizational policies and practices to reflect changes in regulatory requirements and industry standards.

Audit, Monitoring, and Risk Management

• Lead and coordinate regulatory audits, inspections, and surveys conducted by agencies (e.g., HHS OIG, CMS) and oversee internal and external audits related to compliance matters. Develop monitoring tools, perform periodic reviews, and collaborate with departments to identify compliance risks and implement corrective action plans.

Training and Education

• Develop and deliver training programs on regulatory compliance topics to promote a culture of compliance and ethical conduct across the organization.

Stakeholder Collaboration and Communication

• Serve as a liaison between compliance, legal, operations, and clinical leadership teams to foster transparency, responsiveness, and collaboration. Maintain compliance performance reporting and metrics and communicate effectively with stakeholders to ensure accountability and transparency.

Team Leadership and Development

• Mentor, develop the compliance team, fostering a culture of integrity, collaboration, and respect. Perform other duties as assigned to support the growth and maturity of the Compliance Program.

Knowledge, Skills and Abilities

• High ethical standards and commitment to compliance.
• Ability to interpret and apply complex regulatory requirements to organizational policies and procedures.
• Knowledge of and experience in working with federal and state research and healthcare compliance laws, regulations and sub-regulatory guidance preferred.
• Demonstrated proficiency in applying compliance and ethics standards in complex health care environments.
• Possess excellent organization, attention to detail, technical and analytical skills. Can gather relevant information systematically, break down problems into essential components and can make sound decisions. Approach problems with curiosity and open-mindedness and offer new ideas, solutions and/or options. Demonstrate discretion, diplomacy, and good judgment.
• Possess effective communication and presentation skills, clearly and concisely express ideas in groups and one-to-one conversations, formal and informal documents. Adapt strong writing and communications styles to fit the audience.
• Self-starter, positive attitude, ability to work independently, enjoys learning and staying current with industry developments, regulations, and best practices.
• Demonstrate knowledge in setting and achieving challenging goals.
• Adaptability to a fast-paced environment
• Ability to thrive in a dynamic work setting, balancing multiple responsibilities while maintaining effectiveness.
• Strong interpersonal skills to foster a collaborative team environment.

Minimum Job Qualifications

• Bachelor's Degree, JD, or MPH required.
• Certification in Health Care Compliance (CHC) preferred. Willingness to obtain certification within the first 12 months of employment.
• Seven to ten years of experience in regulatory healthcare compliance required.
• Three years in a leadership role required.

Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.