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Compliance Lead-Medical Device

Burnett Specialists

Austin, TX

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JOB DETAILS
SKILLS
Billing, Biology, Biotech and Pharmaceutical, Consulting, Contract Management, Corporate Compliance, Corrective Action, Cross-Functional, Documentation, Finance, Healthcare, Healthcare Reimbursement, Legal, Maintain Compliance, Marketing, Medical Affairs, Medical Equipment, Project/Program Management, Regulations, Regulatory Requirements, Risk Management, Standard Operating Procedures (SOP), Statutory Laws
LOCATION
Austin, TX
POSTED
29 days ago

Global medical device corporation is seeking a Professional Education Compliance Lead to be responsible for overseeing all compliance aspects of professional education programs involving physician engagement and payment. This role ensures adherence to U.S. and global regulatory requirements and internal policies, and serves as a key partner to the Office of Ethics and Compliance, Legal, Finance, Medical Affairs, and Education teams.  This role will also be serving as a lead for professional education programs as needed. 

 

Key Responsibilities
  • Lead all compliance aspects of professional education activities
  • Ensure compliance with applicable medical device laws, regulations, and industry codes (e.g., Anti-Kickback Statute, Sunshine/Open Payments, AdvaMed Code)
  • Oversee compliant engagement, contracting, and payment of physicians for education, training, and consulting activities
  • Manage compliance for all U.S. physician engagements and those conducted outside the U.S. (OUS), collaborating with OUS teams to ensure local compliance, documentation, and proof of performance
  • Oversee and support cross-border physician agreements, ensuring alignment with U.S. and local regulatory requirements
  • Generate and execute physician contracts, manage speaker training completion, fair market value (FMV) determinations, and payment methodologies
  • Develop, maintain, and enhance policies, SOPs, and internal controls related to physician engagements and payments Partner cross-functionally with Legal, Finance, Medical Affairs, Education, and external vendors to ensure compliant program execution Oversee tracking, documentation, reporting, and transparency requirements for physician payments and transfers of value
  • Review and approve all physician invoices, including honorarium and reimbursement ensuring full compliance, following company and division guidelines.
  • Provide compliance guidance, training, and education to internal teams and vendors
  • Identify, assess, and mitigate compliance risks related to professional education programs – all aspects audit ready
  • Support audits, investigations, and corrective actions related to physician engagements 

Required Qualifications:
  • BA/BS degree in business, healthcare, marketing, compliance, legal studies, or an equivalent combination of education and work experience
  • 5 - 7 years of experience in compliance, legal, medical affairs, marketing, or professional education within the medical device, pharmaceutical, or life sciences industry
  • Familiarity with physician engagements and compliance

Preferred Qualifications:
  • Strong working knowledge of physician engagement and payment compliance, including Anti-Kickback Statute, Sunshine/Open Payments, and industry codes (e.g., AdvaMed)
  • Strong working knowledge of GPAS
  • Experience managing physician contracts, FMV, and payment processes
  • Experience supporting global or cross-border physician engagements

About the Company

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Burnett Specialists

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