Sr. Regulatory Counsel, Healthcare

GeneDx (Nasdaq: WGS) delivers personalized and actionable health insights to inform diagnosis, direct treatment, and improve drug discovery. The company is uniquely positioned to accelerate the use of genomic and large-scale clinical information to enable precision medicine as the standard of care. GeneDx is at the forefront of transforming healthcare through its industry-leading exome and genome testing and interpretation services, fueled by the world’s largest, rare disease data sets. For more information, please visit www.genedx.com

Primary Responsibilities

The Senior Regulatory Counsel, Healthcare will provide strategic legal guidance on complex healthcare regulatory matters affecting GeneDx, a publicly traded commercial genetics testing laboratory. This position involves advising senior leadership, business units, and cross-functional teams on compliance with healthcare laws, regulations, and industry standards, including those related to healthcare fraud and abuse, privacy and security, reimbursement, and licensing. The Senior Regulatory Counsel will play a key role in identifying and mitigating legal risks, navigating regulatory challenges, and supporting the organization’s business objectives within a highly regulated healthcare environment. Additional duties may be assigned.

• Regulatory Compliance: Provide expert legal counsel to senior management and business teams on a wide range of healthcare regulatory issues, including compliance with federal, state, and local regulations (e.g., HIPAA, Stark Law, Anti-Kickback Statute, False Claims Act, FDA regulations, and CMS guidelines), working closely with the regulatory affairs team on CLIA, CAP and FDA approvals as required.
• Risk Mitigation & Management: Identify, assess, and advise on potential legal risks associated with regulatory and operational activities. Develop strategies to mitigate risks and ensure compliance with evolving healthcare laws and regulations.
• Regulatory Monitoring: Stay abreast of regulatory and legal developments in the healthcare industry and ensure that the organization is prepared for changes in the regulatory landscape. Communicate potential risks and opportunities to senior management and other stakeholders.
• Government Relations & Agency Interactions: In collaboration with the regulatory and laboratory compliance teams, serve as a legal liaison with governmental agencies such as the Centers for Medicare & Medicaid Services (CMS), the Office of Inspector General (OIG), the Department of Health and Human Services (HHS), the Food and Drug Administration (FDA), and other relevant regulatory bodies. Manage responses to audits, investigations, and regulatory inquiries.
• Policy Interpretation and Strategy: Analyze and interpret new and existing healthcare laws and regulations, and help inform the organization’s policies and practices to ensure compliance. Provide guidance on the impact of regulatory changes and industry developments.
• Transactional Support: Provide regulatory support in mergers, acquisitions, joint ventures, and other strategic business transactions involving healthcare providers, payers, and pharmaceutical companies. Conduct regulatory due diligence and advise on deal structures to minimize legal and regulatory risks.
• Healthcare Fraud and Abuse: Advise on compliance with healthcare fraud and abuse laws, including structuring business arrangements (e.g., physician compensation arrangements, referral agreements, and contracting structures) to comply with the Anti-Kickback Statute, Stark Law, and similar state laws.
• Privacy and Data Security: Advise on the legal and regulatory aspects of healthcare data privacy and security, including compliance with the Health Insurance Portability and Accountability Act (HIPAA) and applicable state privacy laws. Support the organization in managing risks related to healthcare data breaches and cybersecurity issues.
• Training and Education: Develop and lead internal training programs on regulatory matters, helping to ensure that key stakeholders, including compliance teams, business leaders, and staff, understand and comply with healthcare regulatory requirements.
• Contractual Review and Compliance: Review and provide legal guidance on healthcare-related agreements, including payer/provider contracts, supplier agreements, and vendor relationships, ensuring compliance with healthcare regulations and industry best practices.

Qualifications

• The successful candidate will hold a law degree from an accredited law school and be licensed in good standing to practice law in at least one state and one federal jurisdiction within the United States
• 8-10 years of relevant healthcare regulatory law experience
• Proven track record in advising healthcare organizations on regulatory matters, managing legal risks, and providing practical, business-oriented legal advice
• Experience in managing regulatory investigations, audits, and enforcement actions by federal or state agencies
• A commercially oriented attorney with strong strategic, commercial and interpersonal skills who understands the nuances of complicated regulatory issues and is well able to think creatively to problem solve and mitigate risk while supporting business objectives
• Superior writing skills with an ability to present nuanced, complicated and content rich issues clearly and succinctly
• Demonstrated ability to exercise independent judgment effectively
• Ability to draft and implement key corporate policies and procedures to empower and enable associates to achieve business objectives in a compliant manner

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Science - Minded, Patient - Focused.

At GeneDx, we create, follow, and are informed by cutting-edge science. With over 20 years of expertise in diagnosing rare disorders and diseases, and pioneering work in the identification of new disease-causing genes, our commitment to genetic disease detection, discovery, and diagnosis is based on sound science and is focused on enhancing patient care.

Experts in what matters most.

With hundreds of genetic counselors, MD/PhD scientists, and clinical and molecular genomics specialists on staff, we are the industry’s genetic testing experts and proud of it. We share the same goal as healthcare providers, patients, and families: to provide clear, accurate, and meaningful answers we all can trust.

SEQUENCING HAS THE POWER TO SOLVE DIAGNOSTIC CHALLENGES.

From sequencing to reporting and beyond, our technical and clinical experts are providing guidance every step of the way:

TECHNICAL EXPERTISE

• High-quality testing: Our laboratory is CLIA certified and CAP accredited and most of our tests are also New York State approved.
• Advanced detection: By interrogating genes for complex variants, we can identify the underlying causes of conditions that may otherwise be missed.

CLINICAL EXPERTISE

• Thorough analysis: We classify variants according to our custom adaptation of the most recent guidelines. We then leverage our rich internal database for additional interpretation evidence.
• Customized care: Our experts review all test results and write reports in a clear, concise, and personalized way. We also include information for research studies in specific clinical situations.
• Impactful discovery: Our researchers continue working to find answers even after testing is complete. Through both internal research efforts and global collaborations, we have identified and published hundreds of new disease-gene relationships and developed novel tools for genomic data analysis. These efforts ultimately deliver more diagnostic findings to individuals.

Learn more About Us here.

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