Regulatory Affairs / Agency Coordination Specialist ARPA-H

Company Description 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. Job Description 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. Qualifications 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. Additional Information • 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) Original job Regulatory Affairs / Agency Coordination Specialist ARPA-H posted on GrabJobs ©. To flag any issues with this job please use the Report Job button on GrabJobs. Apply tot his job