Odyssey Systems Consulting Group
Frederick, MD
Position Summary
Odyssey is looking for a Regulatory Affairs Support (Warfighter Expeditionary Medicine and Treatment) to support the Defense Health Agency (DHA) located at Ft. Detrick, MD. This Regulatory Affairs Support SME provides specialized guidance and in-depth expertise on FDA regulatory requirements for the WEMT division. This technical resource ensures successful product development, submission, and lifecycle management for drugs, biologics, and medical devices utilized in expeditionary medicine. ***Contingent upon contract award***
Responsibilities
Duties include, but are not limited to: Provide expert advice and guidance on the application of FDA regulations to the development of military-relevant medical solutions. Develop and review regulatory strategies, submission planning, dossier preparation, and communication with regulatory agencies. Prepare and review regulatory...