Full-Time Compliance Manager

Essential Duties and Responsibilities:

Training & Education

• Design and deliver compliance training for Company personnel, including sales and marketing teams, business development, client services and medical affairs.
• Educate staff on specific compliance risks related to diagnostics

Policy and Program Management

• Assist in the ongoing development, implementation, and maintenance of the compliance program tailored to oncology and screening diagnostics operations.
• Draft and update SOPs and internal policies governing laboratory practices, promotion and sale of healthcare services, billing and reimbursement.
• Support the quarterly Compliance committee meetings, record meeting minutes and agenda planning and follow up.

Regulatory Compliance

• Monitor and interpret healthcare laws, regulations, and industry guidance relevant to diagnostic laboratories, including:
• Clinical Laboratory Improvement Amendments (CLIA)
• Food and Drug Administration (FDA) regulations for Laboratory Developed Tests (LDTs) and IVDs
• Anti-Kickback Statute, Stark Law, and Sunshine Act (as applicable)
• Monitor and triage incoming inquiries through the Compliance portal and the anonymous hotline

Other

• Develop a keen awareness of risks associated with the marketing and sale of cancer diagnostic products to proactively address issues and identify opportunities for process improvements
• Maintain current and accurate knowledge of existing and emerging trends, enforcement actions, industry best practices and laws and regulations regarding healthcare compliance and interactions with healthcare professionals
• Assist with internal investigations, as required, to promote a culture of zero tolerance for non-compliance, with heightened focus on timely follow up on incoming inquiries and complaints

Bachelor’s degree with a minimum of 5 years of experience in a compliance role in the medical devices or diagnostics industry
Juris Doctorate preferred
Working and robust knowledge of the clinical laboratory, diagnostic, and medical device industries and enforcement of associated local regulations
Certification in Healthcare Fraud & Abuse Law Compliance preferred
Strong research, analytical, and problem-solving skills
Demonstrated ability to advise and collaborate with business leaders and key stakeholders on compliance issues, facilitating risk assessment and developing practical business solutions
Training and presentation experience in various settings including live audience and video conferencing
Excellent strategic and analytical skills with the ability to help business partners identify compliant solutions to novel issues
Ability to articulate risk without being an “alarmist”
Excellent verbal and written communication skills
Knowledge of privacy laws (GDPR, HIPAA) a plus
In-depth knowledge of U.S. healthcare regulations and diagnostic testing standards.
Strong analytical and problem-solving capabilities.
Proficiency in documenting processes and preparing audit-ready materials.
Ability to work independently in a fast-paced, evolving regulatory environment.
Detail-oriented, with a strong sense of accountability and discretion.

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