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Federal Regulatory Affairs Manager

Federal Regulatory Affairs Manager
Organization: American Heart Association
Location: Philadelphia, PA/Danbury, CT/Providence, RI/New Haven, CT/Boston, MA/Bridgeport, CT/Gaithersburg, MD/Baltimore, MD/Washington, DC
Date Posted: 02/06/2024

Overview

Now is the time to join us and make a difference. Be a relentless force for a world of longer, healthier lives. Here at the American Heart Association, you matter and so does your career.

The American Heart Association has a phenomenal opportunity for a Regulatory Affairs Manager with our Federal Advocacy Team in our Washington, DC office (home-based work arrangements available).

Under the direction of the Director, Federal Regulatory Affairs, you would be responsible for monitoring, analyzing, and drafting responses to a prescribed set of federal regulatory and reimbursement-related issues and representing the American Heart Association before federal agencies. The primary focus of your regulatory work would be the Department of Health and Human Services (HHS) and specifically, the Centers for Medicare and Medicaid Services (CMS), Center for Medicare & Medicaid Innovation (CMMI), and Food and Drug Administration (FDA). Major topics would include rules that impact Affordable Care Act (ACA) markets and patient protections, Medicare coverage determinations and Medicare payment rules, certain Medicaid coverage issues, and FDA initiatives focused on drug/device development and safety. As part of your work, you would also find opportunities for high level volunteers and staff to serve on appropriate federal regulatory and oversight bodies, including advisory panels and committees. Other duties may include providing support on proposals related to delivery system reform, quality improvement, digital health, and other issues as assigned.

The Association offers many resources to help you maintain work-life harmonization through your changing needs and life situations. To help you be successful, you will have access to Heart U, our award-winning corporate university, as well as additional training and support, locally.

#TheAHALife is our company culture, our way of life, reflecting our diversity, equity & inclusion, our focus on work-life harmonization and our Guiding Values. Discover why you will Be Seen. Be Heard. Be Valued™ at the American Heart Association by following us on LinkedIn, Instagram, Facebook, X (formerly Twitter), and at heart.org.

Responsibilities

Monitor regulatory issues in defined areas daily and identify opportunities to advance the American Heart Association’s priorities.

Provide verbal and written updates and briefings to American Heart Association leadership and volunteers.

Work with appropriate staff, volunteers, and partners to prepare regulatory comments and correspondence to federal agencies.

Request and participate in meetings with federal agency staff.

Work with appropriate field staff to coordinate actions between the federal and state level.

Brief high-level staff and volunteers in preparation for federal agency hearings and meetings. This includes preparation of written and oral statements and other presentations.

Maintain and develop new relationships with federal agency staff and coalition partners. Facilitate and/or initiate communications between high-level staff and volunteers and key federal agency personnel.

Build and maintain positive relationships with staff in other departments, while monitoring and reporting on issues related to their work.

Serve as a resource to other advocacy staff on access-related legislative issues.

Attend advisory committee meetings, federal agency meetings, coalition meetings, press conferences, issue briefings, hearings, etc.

Provide input for Federal Advocacy communications, as necessary.

Qualifications

Bachelor’s degree in Political Science, Public Policy, or a related field.

Minimum of five (5) years of experience in and knowledge of regulatory affairs.

Knowledge of federal executive branch procedures and policies.

Knowledge of health care access issues and prior experience writing regulatory comment letters and interacting with policymakers.

Ability to identify issues and opportunities in the regulatory environment that will help advance the mission of the American Heart Association.

Excellent writing and oral communication skills and the ability to think analytically.

Ability to operate with minimum supervision, take initiative, and produce results.

Here are some of the preferred skills we are looking for:

Juris Doctorate or Master’s degree in Public Policy, Public Administration, Political Science or related field desirable.

Experience working within a federal agency such as CMS or FDA desirable.

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Washington, D.C. | June 10, 2024

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