Federal Regulatory Affairs Analyst – Health Innovation

We are seeking a strategic, relationship-oriented Regulatory Specialist to serve as a key interagency liaison between ARPA-H (Advanced Research Projects Agency for Health) and the U.S. Food and Drug Administration (FDA). In this pivotal role, you’ll help drive cross-agency alignment, regulatory clarity, and collaborative opportunities that enable breakthrough biomedical innovations to advance toward commercialization and patient impact.The ideal candidate brings first-hand FDA experience, excels at managing multi-stakeholder communications, and thrives in fast-paced, mission-driven environments. Prior exposure to ARPA-style innovation programs (e.g., DARPA, ARPA-E, BARDA) is highly desirable.Key Responsibilities:Build and maintain productive relationships with FDA personnel and other federal agency contacts.Provide direct regulatory coordination and strategic guidance to ARPA-H Program Managers in collaboration with FDA liaisons.Support ARPA-H’s Project Accelerator Transition Innovation Office (PATIO) by identifying and facilitating access to relevant regulatory consultants and tools.Track and support intergovernmental engagements aligned with ARPA-H priorities, including agencies under HHS and beyond.Maintain and update engagement records within the internal tracking system and produce regular interagency collaboration dashboards.Draft briefing materials, regulatory engagement summaries, and written reports for ARPA-H leadership.Develop tailored presentations for external agency meetings and manage scheduling, prep, and logistics for interagency engagements.