Director - US Regulatory Affairs

PURPOSE AND SCOPE:

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.

PRINCIPAL DUTIES AND 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

ADDITIONAL RESPONSIBILITIES:

• 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

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 strongly preferred (JD, MBA, PhD, or Master’s in Health Policy, Public Health, or related field)

EXPERIENCE AND REQUIRED SKILLS:

• 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
• Experience within dialysis, pharmaceutical, or medical device industries strongly preferred
• 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

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