Regulatory Affairs Subject Matter Expert I

About the role

Position: Regulatory Affairs Subject Matter Expert I. Location: Fort Detrick, MD. Work Environment: Hybrid / Telework Eligible (routine and situational telework authorized). Clearance Required: TIER 1: Non‑critical sensitive position (must be able to obtain and maintain). Status: Contingent.

Responsibilities

• Provide expert advice and guidance on the application of FDA regulations to the development of military‑relevant medical solutions.
• Develop and review regulatory strategies, submission planning, dossier preparation, and communication with regulatory agencies.
• Prepare and review regulatory submissions including INDs, NDAs, PMAs, and 510(k)s.
• Evaluate and interpret regulatory guidelines and policies to assess their impact on developmental programs.
• Conduct gap analyses of existing processes against current regulatory requirements and provide mentorship to team members on best practices.

Requirements

Bachelor's Degree in a scientific, health, or regulatory field. At least 8 years of full‑time work experience in regulatory affairs for medical products (drugs, biologics, or devices). Proven experience preparing and reviewing formal FDA submissions.

Preferred Qualifications

• Regulatory Affairs Certification (RAC).
• Experience working with DoD‑sponsored medical product development initiatives.

Benefits

• Health (PPO & HDHP) Insurance
• Dental
• Vision
• STD & LTD
• Basic Life Insurance
• 401k Company Match
• Voluntary Products

Pay

Anticipated Salary Range: $95,000 - $125,000.

Schedule

Hybrid / Telework Eligible (routine and situational telework authorized).