Destava

Senior DoD Regulatory Affairs Specialist – Medical Products - Telework

Arcetyp is hiring for Senior DoD Regulatory Affairs Specialist – Medical Products - 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 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. -…

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