Regulatory Affairs Specialist - Military Medical Devices

Odyssey Systems Consulting Group, Ltd. seeks a Regulatory Affairs Support SME to assist the Defense Health Agency at Ft. Detrick, MD. The role focuses on FDA regulatory requirements for the WEMT division, guiding product development, submissions, and lifecycle management for drugs, biologics, and medical devices used in expeditionary medicine. Responsibilities include shaping regulatory strategies, preparing submissions (INDs/NDAs/PMAs/510(k)s), and mentoring teammates on best practices in a DoD