QUALIFICATIONS

• Master’s degree in Healthcare Administration, Regulatory Affairs, Public Health, or related field (JD or advanced regulatory certification preferred).
• 12+ years of progressive leadership experience in regulatory affairs, quality, or compliance within healthcare, life sciences, or fertility/women’s health.
• Deep knowledge of FDA, HIPAA, IRB, OHRP, OSHA, QUAD A, SART, and state regulatory standards.
• Proven ability to lead cross-functional teams and manage enterprise-level regulatory and quality programs.
• Strong background in risk management, liability/malpractice insurance, and quality assurance frameworks.
• Exceptional leadership, communication, and stakeholder management skills with demonstrated ability to influence at the executive and board level.

ABOUT THE ROLE

The Vice President, Regulatory Affairs & Quality will provide enterprise leadership and strategic oversight of Kindbody’s regulatory, compliance, and quality assurance functions. This role ensures that Kindbody maintains the highest standards of safety, clinical compliance, and regulatory integrity across all facilities and programs while partnering with executive leadership to support growth and innovation.

RESPONSIBILITIES

• Develop and execute the enterprise regulatory and quality strategy, ensuring compliance with all federal, state, and accreditation requirements (FDA, HIPAA, QUAD A, OSHA, IRB, OHRP, SART, etc.).
• Provide executive oversight for quality improvement initiatives, patient safety programs, and compliance audits across all clinics and service lines.
• Lead and mentor Directors and Senior Managers, ensuring functional excellence across Risk Management, Clinical Compliance, SART reporting, and FDA/Tissue Bank operations.
• Serve as the primary liaison with regulatory agencies, auditors, accreditation bodies, and payors, representing Kindbody in all compliance and regulatory matters.
• Ensure robust risk management programs, including liability/malpractice insurance, HIPAA compliance, and incident reporting frameworks.
• Oversee QA/QI and QAPI programs, implementing performance improvement initiatives and tracking key metrics to enhance patient care and outcomes.
• Monitor state and federal policy changes, assessing impact on clinical and operational practices, and guiding leadership on proactive adjustments.
• Partner with the executive team and clinical leadership to integrate compliance and quality into broader organizational strategy.
• Develop and maintain enterprise dashboards and reporting systems for regulatory compliance, quality metrics, and risk performance.