Regulatory Affairs & Agency Coordination Specialist ARPA-H

If you’re looking to grow your regulatory affairs and government engagement career while supporting breakthrough health innovation at a national level, this is a unique and meaningful opportunity.

We are seeking a motivated and detail-oriented Regulatory Affairs & Agency Coordination Specialist to support interagency collaboration and regulatory strategy for the Advanced Research Projects Agency for Health (ARPA-H). This role is ideal for candidates with 3–5 years of experience, including at least 3 years working directly with or at the U.S. Food and Drug Administration (FDA).

As part of a dynamic, innovation-driven team, you will help guide ARPA-H programs through regulatory planning, engage with key federal stakeholders, and support smooth coordination across agencies.

Key Responsibilities

• Serve as a liaison between ARPA-H program teams and the FDA to support early regulatory planning and engagement.
• Help Program Managers identify and access the right regulatory consultants and resources for their projects.
• Collaborate with the PATIO (Project Accelerator Transition Innovation Office) to align regulatory strategy with project milestones.
• Support the identification of relevant government agencies and programs that align with ARPA-H’s mission.
• Log interagency engagements, track communications, and support reporting on key collaborative efforts.
• Assist in preparing briefing materials, summary reports, and tailored outreach presentations.
• Coordinate meeting logistics with agency contacts.

Required Qualifications

• Bachelor’s degree from an accredited institution (science, public health, or regulatory focus preferred).
• 3–5 years of professional experience, including a minimum of 3 years working directly with the FDA (in regulatory affairs, liaison roles, or policy support).
• Experience supporting regulatory submissions or strategies (e.g., IND, IDE, 510(k)).
• Strong organizational and communication skills.
• Ability to work effectively across multiple teams and priorities.
• Proficient in Microsoft PowerPoint, Excel, and general project tracking tools.

Preferred Qualifications

• Experience working with or supporting ARPA-style organizations (e.g., DARPA, ARPA-E, IARPA).
• Familiarity with HHS or federal interagency operations.
• Knowledge of biomedical or health innovation policy.

• Job Type: Full-Time
• Location: 1301 K Street NW, Washington, DC
• Remote Work: Hybrid (Up to 60% remote)
• Clearance Required: Must be eligible for Public Trust
• Salary Range: $95,000 – $130,000 (Depending on Experience)