Director - US Regulatory Affairs

Fresenius Medical Care • Washington, DC

2d

About The Position

The Director of U.S. Regulatory Affairs is a strategic leader responsible for providing expert regulatory guidance to support the development and execution of public policy initiatives and federal agency engagement strategies. Reporting to the VP of U.S. Public Policy, this role plays a critical part in navigating the evolving regulatory landscape, with a primary focus on the Centers for Medicare & Medicaid Services (CMS). This position is instrumental in analyzing regulatory frameworks, shaping policy strategy, and ensuring alignment between external regulatory requirements and internal business objectives. The Director will serve as a key connector across Government Affairs, business leaders, and subject matter experts to inform decision-making and drive effective engagement with federal agencies.

Requirements

• Bachelor’s degree required
• Minimum of 7+ years of experience in regulatory affairs, health policy, or government affairs within the healthcare industry
• Strong expertise in CMS regulatory frameworks, including coverage, coding, and reimbursement processes
• Deep understanding of both federal and commercial payer environments
• Proven ability to analyze complex regulatory and legislative materials and translate insights into actionable strategies
• Experience developing advocacy materials and supporting policy engagement efforts
• Strong stakeholder management skills with the ability to influence cross-functional teams
• Excellent communication, analytical, and strategic thinking capabilities
• Ability to operate effectively in a highly matrixed, fast-paced environment

Nice To Haves

• Advanced degree strongly preferred (JD, MBA, PhD, or Master’s in Health Policy, Public Health, or related field)
• Experience within dialysis, pharmaceutical, or medical device industries strongly preferred

Responsibilities

• Provide regulatory expertise to support policy development and engagement strategies with federal agencies, including CMS
• Monitor, analyze, and interpret CMS policies and regulations, including billing, coding, reimbursement, and coverage under fee-for-service and commercial plans
• Evaluate proposed rules, legislation, and regulatory changes to assess business impact and develop mitigation strategies
• Develop regulatory analyses, policy briefs, and advocacy materials to support internal and external initiatives
• Serve as a key liaison between Government Affairs and internal stakeholders, including operations, strategy, and business teams
• Facilitate alignment between regulatory strategy and organizational priorities to support informed policy decision-making
• Support and help coordinate engagements with federal agencies, policymakers, and regulatory bodies
• Represent the organization in external meetings with regulatory agencies, industry coalitions, and trade associations (e.g., Kidney Care Partners, AdvaMed, etc.) as needed
• Collaborate cross-functionally to ensure regulatory considerations are integrated into business and policy strategies
• Support enterprise-wide regulatory and policy initiatives
• Contribute to strategic planning and risk mitigation efforts related to regulatory changes
• Provide ongoing insights into the regulatory environment to inform leadership 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