Interim Chief Healthcare Compliance Officer & Associate General Counsel (Compliance)
Duration: 6 Months 
Location: Remote 

Role Overview

We are seeking a senior healthcare compliance leader and digital health attorney to serve as an interim Chief Healthcare Compliance Officer and Associate General Counsel (Compliance). The role is responsible for leading a global healthcare compliance program and providing legal and regulatory guidance for digital health initiatives, including AI-enabled health products, wearables, and medical device–related technologies.

This position sits within the Corporate Compliance & Ethics function and plays a critical leadership role in ensuring healthcare-related business activities comply with applicable federal and international regulations.

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Key Responsibilities

1. Healthcare Compliance Program Leadership

• Lead and manage the organization’s Healthcare Compliance Program
• Oversee compliance policies, procedures, audits, training, and risk assessments
• Ensure program effectiveness and continuous improvement
• Report compliance risks and program status to senior leadership and board-level stakeholders

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2. Compliance Governance & Committee Leadership

• Chair the Healthcare Compliance Committee
• Schedule and lead governance meetings
• Develop agendas, documentation, and committee charters
• Advise on committee structure, membership, and escalation processes

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3. Healthcare Regulatory Legal Advisory

• Provide legal guidance on healthcare fraud and abuse laws, including:
  • Anti-Kickback Statute (AKS)
  • Stark Law
  • False Claims Act (FCA)
• Advise on federal healthcare program compliance requirements
• Review and approve healthcare-related business arrangements

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4. FDA & Digital Health Regulatory Support

• Advise on FDA medical device regulations, including:
  • 510(k)
  • De Novo classification
  • Software as a Medical Device (SaMD)
• Support regulatory strategy for digital health and health technology products
• Provide guidance on international medical device regulations (e.g., EU MDR)

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5. Product & Business Enablement

• Partner with product, engineering, legal, and business teams
• Provide compliance guidance for health-related product launches
• Ensure global scalability of healthcare compliance frameworks
• Enable compliant commercialization of health technologies

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6. Investigations & Risk Management

• Support internal investigations into compliance issues
• Design and implement corrective action plans
• Identify and escalate compliance risks
• Ensure documentation of compliance concerns and resolutions

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7. Training & Communication

• Develop and deliver compliance training programs
• Maintain internal compliance communication channels
• Respond to employee compliance inquiries

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Required Qualifications

• Juris Doctor (J.D.) degree required
• Active Bar membership (licensed attorney)
• 10–15+ years of legal and healthcare compliance experience
• 7–10+ years focused specifically on healthcare regulatory/compliance work
• Strong expertise in:
  • Healthcare fraud & abuse laws (AKS, Stark Law, FCA)
  • Federal healthcare program compliance
• Experience building and managing compliance programs (policies, audits, training, reporting)
• Prior in-house or health-tech/medical industry experience preferred

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Preferred Qualifications

• FDA medical device regulatory experience (510(k), De Novo, SaMD)
• Experience in digital health, medtech, or healthcare technology
• International regulatory exposure (EU MDR or equivalent)
• Experience chairing governance or compliance committees
• Experience supporting compliance program effectiveness assessments (e.g., DOJ guidance)
• Experience with investigations and remediation plans

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Experience Level

• 10–15+ years of combined legal and healthcare compliance experience
• Senior leadership-level compliance or legal role (Director / Senior Director / VP equivalent)

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Key Performance Expectations

• Maintain uninterrupted healthcare compliance program operations
• Ensure timely governance meetings, audits, and reporting deliverables
• Provide accurate, actionable legal and compliance guidance to business teams
• Identify and mitigate regulatory risks proactively
• Support board-level reporting and executive communications
• Maintain high-quality documentation and compliance tracking

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 100.00/hr.