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

Compensation
Base Rate: $165,000-$185,000

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

#J-18808-Ljbffr