2 jobs found in 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...

Position Summary Odyssey is looking for a Regulatory Affairs SME 2 , to support the Defense Health Agency (DHA) at Ft. Detrick, MD.  The Regulatory Affairs Subject Matter Expert 2 acts alongside RA SME 1 to provide specialized regulatory guidance and technical expertise for WPAC initiatives. This expert works to ensure compliance with all federal regulatory requirements and supports the successful development and submission of acute care medical products.   ***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 submissions including INDs, NDAs, PMAs, and 510(k)s. Evaluate and interpret...