Senior DoD Regulatory Affairs Lead — Medical Products

Arcetyp LLC is seeking a Senior DoD Regulatory Affairs Specialist - Medical Products for an onsite role in Fort Detrick, MD. You will develop and review regulatory strategies for drugs, biologics, blood products, and medical devices, and prepare or review INDs, NDAs, PMAs, 510(k)s, technical files, and clinical evaluation reports.

You will also support FDA and other regulatory agency interactions. Minimum qualifications emphasize an in-depth understanding of regulatory requirements across the