Destava

Senior DoD Regulatory Affairs SME – Drugs, Biologics & Medical Devices - Telework

Arcetyp is hiring for Senior DoD Regulatory Affairs SME – Drugs, Biologics & Medical Devices - Telework in Gaithersburg, Maryland. Senior level. First seen October 27, 2026, posted 2 times; open as of November 6, 2026. Jobs taken straight from company career pages — no aggregator in between.

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Company
Arcetyp
Where
Gaithersburg, Maryland
Level
Senior
First seen
October 27, 2026
Postings
2
Listed via
BambooHR

What the posting says

Arcetyp LLC is looking for a Senior DoD Regulatory Affairs SME – Drugs, Biologics & Medical Devices . This position is onsite and located in Fort Detrick, MD. ESSENTIAL JOB FUNCTIONS: - Serve as senior regulatory SME supporting military-relevant drugs, biologics, blood products, medical devices and other medical solutions. - Develop and review regulatory strategies and submission plans. - Prepare/review INDs, NDAs, PMAs, 510(k)s, Technical Files, Clinical Evaluation Reports, meeting packages, audit reports and inspection products. - Support interactions with FDA/regulatory agencies and…

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