PURPOSE AND SCOPE:
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.
PRINCIPAL DUTIES AND 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
ADDITIONAL RESPONSIBILITIES:
- 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
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 (e.g., MPH, MPP, JD, PhD, or MBA) strongly preferred
- Relevant coursework or specialization in public policy, healthcare administration, or regulatory affairs preferred
EXPERIENCE AND REQUIRED SKILLS:
- 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
The 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: $180,000 - $195.000.
Benefit 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
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
