Chief Healthcare Compliance Officer and Associate General Counsel

Overview

A leading organization is seeking a Chief Healthcare Compliance Officer & Associate General Counsel on a contract basis to support its healthcare compliance and legal needs. This is a 100% remote position.

Responsibilities

• Lead and manage the Healthcare Compliance Program, including oversight of policies, procedures, and program effectiveness.
• Provide healthcare regulatory and digital health legal support across product, operational, and sales initiatives.
• Advise on healthcare fraud and abuse laws such as the Anti-Kickback Statute, Stark Law, False Claims Act, and federal healthcare program compliance requirements.
• Oversee compliance monitoring activities, audits, investigations, and corrective action planning.
• Review new and revised business arrangements to ensure compliance with healthcare laws and regulations.
• Serve as Chair of the Healthcare Compliance Committee, including scheduling meetings, developing agendas, maintaining documentation, and advising on committee governance.
• Report healthcare compliance program status, risks, and findings to leadership and support board-level compliance reporting.
• Coordinate internal and external compliance reviews and audits.
• Develop and deliver healthcare compliance training and educational initiatives.
• Manage compliance communication channels, including employee inquiries and issue escalation processes.
• Support investigations into compliance incidents and assist with prevention and remediation efforts.
• Provide legal and regulatory support for digital health products and healthcare-related initiatives.
• Develop and scale compliance infrastructure to support globally distributed consumer and commercial health products.
• Advise on FDA medical device compliance and related digital health regulatory matters.
• Partner cross-functionally with legal, compliance, product, operational, and business stakeholders.
• Provide practical operational and product-focused compliance solutions in fast-paced environments.
• Support compliance efforts involving international medical device regulations and global health regulatory requirements.

Requirements

• Juris Doctor (J.D.) degree with active bar membership.
• 10-15+ years of combined legal and healthcare compliance experience.
• Minimum of 7-10 years focused on healthcare regulatory and compliance work.
• Deep expertise in healthcare fraud and abuse laws, including the Anti-Kickback Statute, Stark Law, False Claims Act, and federal healthcare program compliance.
• Demonstrated experience building, operationalizing, and managing healthcare compliance programs.
• Experience developing compliance policies, procedures, audits, training, risk assessments, and leadership reporting.
• Strong experience reviewing healthcare-related business arrangements for legal and regulatory compliance.
• Strong understanding of healthcare regulatory frameworks and compliance governance.
• Experience advising product, operational, and sales teams on healthcare regulatory matters.
• Ability to develop scalable compliance infrastructure and operational processes.
• Strong communication, organizational, and leadership skills.
• Ability to work effectively in dynamic, fast-paced, and cross-functional environments.
• Experience supporting investigations, corrective action plans, and compliance remediation efforts.

Preferred Qualifications

• Experience with FDA medical device regulatory compliance, including 510(k), De Novo, and Software as a Medical Device (SaMD) classifications.
• Experience with international medical device regulations, including EU MDR and other global regulatory frameworks.
• Experience supporting digital health or health-tech products.
• Experience chairing compliance committees or governance bodies.
• Experience advising on large-scale consumer and commercial healthcare products.
• Familiarity with Department of Justice compliance program effectiveness guidance.
• Experience conducting or supporting compliance effectiveness assessments.

Compensation & Benefits

• Competitive salary range with most candidates hired at the median based on experience and qualifications.
• Contractor benefits available through a third-party Employer of Record after a waiting period for eligible engagements, including:
  • Medical, Dental, Vision coverage
  • 401(k) plan
  • Flexible Spending Account (FSA)
  • Accrued Paid Time Off: Up to 15 days per 12 months on assignment

Location

• This is a fully remote position.

Equal Opportunity

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.