Director - US Regulatory Affairs

Director Of U.S. Regulatory AffairsThe 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 CMSMonitor, analyze, and interpret CMS policies and regulations, including billing, coding, reimbursement, and coverage under fee-for-service and commercial plansEvaluate proposed rules, legislation, and regulatory changes to assess business impact and develop mitigation strategiesDevelop regulatory analyses, policy briefs, and advocacy materials to support internal and external initiativesServe as a key liaison between Government Affairs and internal stakeholders, including operations, strategy, and business teamsFacilitate alignment between regulatory strategy and organizational priorities to support informed policy decision-makingSupport and help coordinate engagements with federal agencies, policymakers, and regulatory bodiesRepresent the organization in external meetings with regulatory agencies, industry coalitions, and trade associations (e.g., Kidney Care Partners, AdvaMed, etc.) as neededCollaborate cross-functionally to ensure regulatory considerations are integrated into business and policy strategiesAdditional Responsibilities:Support enterprise-wide regulatory and policy initiativesContribute to strategic planning and risk mitigation efforts related to regulatory changesProvide ongoing insights into the regulatory environment to inform leadership decision-makingPhysical 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 requiredAdvanced 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 industryStrong expertise in CMS regulatory frameworks, including coverage, coding, and reimbursement processesExperience within dialysis, pharmaceutical, or medical device industries strongly preferredDeep understanding of both federal and commercial payer environmentsProven ability to analyze complex regulatory and legislative materials and translate insights into actionable strategiesExperience developing advocacy materials and supporting policy engagement effortsStrong stakeholder management skills with the ability to influence cross-functional teamsExcellent communication, analytical, and strategic thinking capabilitiesAbility to operate effectively in a highly matrixed, fast-paced environmentThe 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: $165,000-$185,000Benefit 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.