Chief Compliance & Regulatory Officer (CCRO) at Custom Health Inc – Remote, Oregon

About Custom Health

Custom Health is a fully integrated health technology company delivering patient-centric healthcare as a service. Our mission is to transform the patient experience for individuals receiving care at home by improving health outcomes while reducing the total cost of care.

Powered by a modern purpose-built technology platform, high-volume central fill pharmacy operations, and an integrated clinical care team, Custom Health delivers optimized and personalized care for patients in the home with precision and scale.

Custom Health operates across the United States and Canada, supporting regulated healthcare services, pharmacy operations, digital health platforms, and medical device technologies.

Position Overview

The Chief Compliance & Regulatory Officer (CCRO) is responsible for leading enterprise-wide compliance, regulatory affairs, and quality governance across Custom Health, Inc. and its subsidiaries.

The CCRO establishes and maintains the company’s global compliance framework, ensuring that all operations comply with applicable healthcare, pharmaceutical, medical device, privacy, and corporate governance regulations across jurisdictions in which the company operates.

Reporting directly to the Chief Executive Officer, with a dotted-line reporting relationship to the Board of Directors through the Audit & Compliance Committee, the CCRO serves as the independent executive authority responsible for regulatory compliance, ethics, and quality oversight.

The role provides executive oversight of regulatory and quality systems supporting regulated healthcare services, digital health platforms, and medical device operations, ensuring compliance with U.S. FDA regulations, Health Canada requirements, ISO standards, and applicable global regulatory frameworks.

The CCRO also supports public company governance obligations, including regulatory disclosure risk management, internal controls, and compliance oversight expected of a TSX-listed organization.

Key Responsibilities

Enterprise Compliance & Ethics Governance:

• 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.

Regulatory Affairs & Medical Device Compliance:

• 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.

Quality Systems & ISO Compliance:

• Ensure implementation and continuous improvement of enterprise Quality Management Systems (QMS).
• Maintain compliance with ISO 13485 and other applicable quality and regulatory standards.
• Oversee quality governance related to product development, manufacturing, distribution, and post-market surveillance.
• Ensure corrective and preventive action (CAPA), complaint handling, and regulatory reporting processes are properly implemented.

Healthcare Compliance & Privacy:

• Ensure enterprise compliance with HIPAA, healthcare privacy regulations, and applicable federal and state healthcare laws.
• Maintain oversight of compliance with Stark Law, Anti-Kickback Statute, and healthcare fraud and abuse regulations.

Enterprise Risk & Compliance Monitoring:

• Conduct enterprise compliance risk assessments and regulatory gap analyses.
• Identify, assess, and mitigate regulatory, operational, and reputational risks.
• Establish monitoring and auditing frameworks to ensure ongoing compliance.

Auditing, Investigations & Corrective Actions:

• Oversee internal compliance audits and regulatory readiness assessments.
• Lead investigations into potential compliance violations.
• Ensure implementation of corrective and preventive actions and regulatory remediation programs.

Compliance Training & Code of Conduct:

• Develop and maintain enterprise compliance education and training programs.
• Maintain the company’s Code of Conduct and ethics reporting systems, including confidential reporting channels.
• Strategic Initiatives & Mergers and Acquisitions
• Provide compliance and regulatory oversight for corporate strategy, partnerships, and acquisitions.
• Conduct regulatory and compliance due diligence for mergers and acquisitions.
• Ensure acquired entities are integrated into the enterprise compliance and quality framework.

Board Governance & Public Company Compliance:

• Provide regular reports to the Board of Directors and Audit & Compliance Committee regarding compliance program effectiveness.
• Report on regulatory developments, investigations, audit outcomes, and enterprise risk exposure.
• Support compliance with public company governance standards, disclosure controls, and regulatory reporting obligations.
• Ensure strong corporate governance practices aligned with TSX-listed company expectations.

Qualifications

• 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

• FDA medical device regulations and Quality System Regulation (21 CFR Part 820)

• Health Canada medical device regulatory frameworks

• ISO 13485 quality management systems

• HIPAA and healthcare privacy regulations

• Stark Law and Anti-Kickback Statute

• Healthcare fraud and abuse laws

Skills

• Strong executive leadership and regulatory strategy capabilities

• Deep expertise in compliance risk management and regulatory governance

• Ability to engage effectively with regulators, executive leadership, and boards of directors

• Excellent communication and organizational leadership skills