Chief Compliance & Regulatory Officer

Role Overview

• Develop and maintain the enterprise-wide compliance and ethics program across Custom Health, Inc. and all subsidiaries.
• Establish governance structures, policies, and procedures supporting regulatory compliance, corporate integrity, and ethical conduct.
• Promote a culture of accountability, transparency, and compliance throughout the organization.
• Ensure compliance functions operate with appropriate independence from operational management.
• Provide executive oversight for regulatory strategy and compliance related to medical devices, digital health technologies, and regulated healthcare services.
• Ensure compliance with U.S. FDA regulations (including 21 CFR Part 820 Quality System Regulation), Health Canada Medical Device Regulations, and other applicable international regulatory frameworks.
• Oversee regulatory submissions, approvals, certifications, and lifecycle management.
• Serve as executive liaison with regulatory agencies, notified bodies, and external auditors.
• Ensure implementation and continuous improvement of enterprise Quality Management Systems (QMS).
• Maintain compliance with ISO 13485 and other applicable quality and regulatory standards.
• Ensure corrective and preventive action (CAPA), complaint handling, and regulatory reporting processes are properly implemented.
• Ensure enterprise compliance with HIPAA, healthcare privacy regulations, and applicable federal and state healthcare laws.
• Conduct enterprise compliance risk assessments and regulatory gap analyses.
• Oversee internal compliance audits and regulatory readiness assessments.
• Develop and maintain enterprise compliance education and training programs.
• Provide regular reports to the Board of Directors and Audit & Compliance Committee regarding compliance program effectiveness.

Requirements

• Bachelor’s degree required with an advanced degree preferred (JD, Master’s degree, or equivalent).
• Professional certification preferred (CHC, CCEP, RAC, or equivalent).
• 15+ years of senior leadership experience in healthcare compliance, regulatory affairs, or quality systems.
• Experience within medical device, digital health, pharmacy services, or healthcare technology sectors.
• Experience interacting with regulatory authorities, boards of directors, and executive leadership teams.
• Experience supporting public company governance or companies preparing for public listing preferred.
• Knowledge of FDA medical device regulations and Quality System Regulation (21 CFR Part 820).
• Knowledge of Health Canada medical device regulatory frameworks.
• Knowledge of ISO 13485 quality management systems.
• Knowledge of HIPAA and healthcare privacy regulations.
• Knowledge of Stark Law and Anti-Kickback Statute.
• Knowledge of healthcare fraud and abuse laws.

Benefits

• Health insurance
• Professional development