Program Management - Program Manager V
Spectraforce
Menlo Park, California
2 days ago
Job Description
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.
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
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
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
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)
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
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
7. Training & Communication
- Develop and deliver compliance training programs
- Maintain internal compliance communication channels
- Respond to employee compliance inquiries
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
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
Experience Level
- 10–15+ years of combined legal and healthcare compliance experience
- Senior leadership-level compliance or legal role (Director / Senior Director / VP equivalent)
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
Applicant Notices & Disclaimers
- For information on benefits, equal opportunity employment, and location-specific applicant notices, click here
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.