Director, U.S. Public Policy - Medical Devices and Drugs

Director, U.S. Public Policy at Fresenius Medical Care

PURPOSE AND SCOPE:

The Director of U.S. Public Policy (Medical Devices and Drugs) is responsible for developing and executing policy strategies that advance market access, coverage, coding, payment, and adoption of the company's medical device and drug portfolio. Reporting to the SVP, Head of Global Government Affairs & Policy, this role serves as Government Affairs’ policy partner to the medical device and drug business. This role serves as the lead policy expert on federal healthcare reimbursement and payment policy related to medical devices and drugs, with a primary focus on the Centers for Medicare & Medicaid Services (CMS), Medicare payment systems.

This leader will drive policy initiatives impacting device coverage, coding, payment, value-based care, and technology assessment across Medicare and Medicaid programs while also supporting policy matters related to pharmaceutical products as appropriate and proactively monitoring regulatory changes, legislation and industry trends. The role requires deep expertise in CMS reimbursement pathways, regulatory policy, and healthcare financing, as well as the ability to influence policymakers, regulators, and industry stakeholders to support patient access to innovative technologies. The Director will serve as a key liaison between external stakeholders and internal business leaders to ensure alignment between policy strategy and organizational objectives.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Develop and execute U.S. public policy strategies that support favorable coverage, coding, payment, and market access outcomes for the company's medical device portfolio, while providing policy support for drug-related reimbursement issues where appropriate.

• Lead policy development and advocacy related to CMS reimbursement frameworks, including Medicare fee-for-service payment systems, value-based payment models, technology add-on payments, outpatient and physician payment methodologies, and emerging coverage pathways for innovative medical technologies.

• Monitor, analyze, and influence CMS policies affecting medical devices, including national and local coverage determinations, coding systems, payment methodologies, quality programs, and health technology assessment initiatives.

• Evaluate proposed legislation, regulations, and agency guidance to assess impacts on device reimbursement, patient access, provider adoption, and business strategy, and develop corresponding advocacy and mitigation plans.

• Monitor and assess FDA regulatory policies affecting medical devices, including clinical trial requirements, product approvals, post-market surveillance, real-world evidence, and innovation initiatives. 

• Develop policy briefs, position papers, reimbursement analyses, advocacy materials, and strategic recommendations for executive leadership and business partners.

• Represent the organization before federal agencies, policymakers, and key stakeholders, including CMS, FDA, Congress, and relevant Executive Branch officials.

• Build and maintain strong relationships with CMS leadership, reimbursement experts, policymakers, medical specialty societies, patient advocacy organizations, trade associations, and other healthcare stakeholders.

• Engage actively with industry coalitions and trade associations, including AdvaMed, Kidney Care Partners, and other organizations influencing medical device reimbursement and healthcare policy.

• Partner closely with commercial, market access, health economics, regulatory, clinical, and corporate strategy teams to align policy priorities with business objectives and reimbursement strategies.

• Serve as the internal subject matter expert on medical device reimbursement policy, Medicare payment systems, coverage pathways, coding strategies, healthcare financing, and related federal healthcare policy developments.

ADDITIONAL RESPONSIBILITIES:

• Support enterprise-wide advocacy initiatives and public affairs strategies related to healthcare innovation, reimbursement, and patient access.

• Identify emerging reimbursement and payment policy risks and opportunities that could impact the company's medical technology portfolio.

• Develop long-range policy strategies to enhance patient access and provider adoption of innovative medical devices.

• Participate in executive and business planning discussions to ensure reimbursement, coverage, and healthcare policy considerations are incorporated into strategic decision-making.

• Provide thought leadership on evolving healthcare payment models, value-based care initiatives, and their implications for medical technologies.

PHYSICAL DEMANDS AND WORKING CONDITIONS:

The physical demands and work environment characteristics described here are representative of those encountered while performing the

essential functions of this role. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

EDUCATION:

• Bachelor’s degree required

• Advanced degree (e.g., MPH, MPP, JD, PhD, or MBA) strongly preferred

• Relevant coursework or specialization in public policy, healthcare administration, or regulatory affairs preferred

EXPERIENCE AND REQUIRED SKILLS:

• Minimum of 10+ years of experience in healthcare policy, government affairs, reimbursement policy, market access, or regulatory strategy, with significant experience in the medical device industry strongly preferred.

• Deep expertise in CMS reimbursement policy, including Medicare coverage, coding, payment systems, health technology assessment, and market access frameworks for medical devices.

• Extensive knowledge of Medicare and Medicaid reimbursement methodologies, physician payment systems, hospital payment systems, and value-based care initiatives.

• Strong understanding of FDA regulatory processes and their intersection with reimbursement, evidence generation, and market access strategies.

• Demonstrated success influencing CMS policy outcomes, coverage determinations, payment methodologies, coding decisions, and legislative initiatives impacting medical technologies.

• Proven experience developing reimbursement-focused advocacy strategies and building coalitions to advance policy objectives.

• Established relationships with key CMS, congressional, industry association, and healthcare stakeholder audiences preferred.

• Exceptional analytical, strategic thinking, and policy development capabilities, with the ability to translate complex regulatory and reimbursement issues into actionable business strategies.

• Strong executive presence and ability to effectively represent the organization with senior government officials, healthcare stakeholders, and industry leaders.

• Outstanding written and verbal communication skills.

• Proven ability to work cross-functionally across commercial, market access, regulatory, clinical, and executive leadership teams.

The rate of pay for this position will depend on the successful candidate’s work location and qualifications, including relevant education, work experience, skills, and competencies. Base Rate: $180,000 - $195.000. This position is also eligible to participate in the Global Bonus Program. 

Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave

Fresenius Medical Care is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sexual orientation, gender identity, parental status, national origin, age, disability, military service, or other non-merit-based factors