Director - U.S. Public Policy

Fresenius Medical Care • Washington, DC

3d

About The Position

The Director of U.S. Public Policy (Drug, Device & FDA Focus) is responsible for shaping and advancing policy strategies that support market access, reimbursement, and regulatory success for drug products and medical devices. Reporting to the VP of U.S. Public Policy, this role plays a critical part in influencing federal healthcare policy, with a primary focus on the Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration (FDA). This leader will drive the development and execution of policy initiatives related to coverage, coding, and payment, while proactively monitoring regulatory changes, legislation, and industry trends. The Director will serve as a key liaison between external stakeholders and internal business leaders to ensure alignment between policy strategy and organizational objectives.

Requirements

• Minimum of 10+ years of experience in healthcare policy, government affairs, or regulatory strategy, preferably within the pharmaceutical or medical device industry
• Deep knowledge of CMS reimbursement systems, coverage policies, and coding frameworks
• Strong understanding of FDA regulatory processes, including clinical trials and post-market requirements
• Proven experience analyzing legislation and regulatory policy with the ability to translate complex information into actionable strategies
• Demonstrated success influencing policy through advocacy, stakeholder engagement, and coalition participation
• Strong executive presence with the ability to represent the organization externally
• Exceptional communication, analytical, and strategic thinking skills
• Ability to work cross-functionally and navigate complex organizational environments

Nice To Haves

• 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

Responsibilities

• Develop and execute U.S. public policy strategies to secure favorable coverage, coding, and reimbursement outcomes for drug and medical device portfolios
• Monitor, analyze, and interpret CMS and FDA policies, including reimbursement frameworks, user fees, post-market surveillance, and clinical trial regulations
• Evaluate proposed legislation and regulatory rules to assess business impact and develop mitigation strategies
• Create policy briefs, advocacy materials, and strategic recommendations for internal stakeholders and executive leadership
• Represent the organization in meetings with federal agencies, policymakers, and regulatory bodies including CMS and FDA
• Engage with industry coalitions and trade associations (e.g., Kidney Care Partners, AdvaMed, etc.) to influence policy direction and advance shared priorities
• Build and maintain relationships with key policy influencers, government officials, and industry stakeholders
• Collaborate cross-functionally with commercial, regulatory, clinical, and strategy teams to align policy initiatives with business strategy
• Provide subject matter expertise and guidance on evolving healthcare policy landscape and its implications for the organization
• Support enterprise-wide advocacy initiatives and public affairs strategies
• Contribute to long-term policy planning and risk mitigation efforts
• Participate in internal leadership discussions to ensure policy considerations are integrated into strategic decision-making

Benefits

• medical, dental, and vision insurance
• a 401(k) with company match
• paid time off
• parental leave

What This Job Offers

• Job Type: Full-time
• Career Level: Director