Senior Department of Defense Regulatory Affairs Subject Matter Expert — Drugs, Biologics & Medical

Job overview

The Senior Department of Defense Regulatory Affairs Subject Matter Expert — Drugs, Biologics & Medical Devices role is onsite in Fort Detrick, MD. Compensation is not specified; the posting says pay and benefits information will be provided to interested applicants. Arcetyp provides consulting and professional services to federal government, military, and commercial clients. The senior subject matter expert supports regulatory strategy and product development for military-relevant drugs, biologics, blood products, medical devices, and other medical solutions. The role helps teams plan and prepare submissions, engage with regulatory agencies and sponsors, assess product risks and lifecycle strategy, and apply regulatory best practices.

What you'll do

• Serve as a senior regulatory subject matter expert for military-relevant medical products
• develop and review regulatory strategies and submission plans
• prepare or review INDs, NDAs, PMAs, 510(k)s, technical files, clinical evaluation reports, meeting packages, audit reports, and inspection products
• support interactions with FDA and other regulatory agencies and sponsors
• advise product managers and integrated product teams on regulatory risks, opportunities, and lifecycle strategy
• mentor teams on regulatory requirements and practices.

What we're looking for

Skills & competencies

regulatory affairs

senior subject matter expert

department of defense

drugs

biologics

medical devices

fda submissions

fort detrick md

arcetyp llc

onsite

u.s. citizenship required

no h-1b sponsorship

Work arrangement

• Weekend coverage required

Benefits & perks

• Medical, dental, and vision insurance
• 401(k) with company matching
• tax-deferred savings options
• supplementary benefits
• paid time off
• professional development opportunities.

Why this role

U.S. citizenship required; direct-hire W-2 employee position; employer states it cannot sponsor H-1B visas.

About the employer

Arcetyp LLC is hiring for this role. Industry: All Other Professional, Scientific, and Technical Services. Sector: 54.