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

Custom Health

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Chief Compliance & Regulatory Officer