Custom Health

Chief Compliance & Regulatory Officer

Custom Health

full-time

Posted on:

Location Type: Remote

Location: Tennessee • United States

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Job Level

Lead

About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory compliancequality management systemscompliance risk assessmentsregulatory gap analysescorrective and preventive action (CAPA)complaint handlingregulatory reportingregulatory submissionslifecycle managemententerprise compliance education
Soft Skills
leadershipcommunicationaccountabilitytransparencyorganizational skillsexecutive oversightinterpersonal skillsstrategic thinkingcollaborationproblem-solving
Certifications
Bachelor's degreeJDMaster's degreeCertified in Healthcare Compliance (CHC)Certified Compliance and Ethics Professional (CCEP)Regulatory Affairs Certification (RAC)