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Senior DoD Regulatory Affairs Specialist – Medical Products - Telework

Arcetyp LLC • Gaithersburg, MD, US • published 2026-09-29 08:55:30.959481

Description

Arcetyp LLC is a growing small business that provides a broad range of consulting services to US Federal Government, US Military, and Commercial clients. Services include Management \& IT Consulting, Program \& Project Management, and Professional \& Admin Services. We accept direct hire candidates only, W2 employee hires. We do not accept 1099 independent consultants. We do not accept staffing firms. We do not accept corp\-to\-corp (C2C) candidates. We can't sponsor H1B. Arcetyp LLC is looking for a **Senior DoD Regulatory Affairs Specialist \- Medical Products**. This position is onsite and located in Fort Detrick, MD. **ESSENTIAL JOB FUNCTIONS:** * Develop and review regulatory strategies for drugs, biologics, blood products, and medical devices. * Prepare/review INDs, NDAs, PMAs, 510(k)s, technical files and clinical evaluation reports. * Support FDA/regulatory agency interactions. * Conduct regulatory gap analyses. * Advise product managers and IPTs on regulatory risk and product lifecycle strategy. **NECESSARY SKILLS AND KNOWLEDGE:** * FDA regulatory affairs. * Medical product development lifecycle. * Drugs, biologics and/or medical devices. * Regulatory submissions. * Clinic...

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