Regulatory Affairs Support (Warfighter Expeditionary Medicine and Treatment)

Odyssey Systems Consulting Group, Ltd.•Frederick, CO

5d•Onsite

About The Position

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.

Requirements

Must be a US citizen.
Ability to Obtain NACI.
Bachelor's Degree in a scientific, health, or regulatory field.
At least 8 years of full-time work experience in regulatory affairs for medical products (drugs, biologics, or devices).
Proven experience preparing and reviewing formal FDA submissions.

Nice To Haves

Regulatory Affairs Certification (RAC).
Experience working with DoD-sponsored medical product development initiatives.
Experience with DHA/USAMMDA preferred.

Responsibilities

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 regulatory guidelines and policies to assess their impact on developmental programs.
Conduct gap analyses of existing processes against current regulatory requirements and provide mentorship to team members on best practices.
Assist in the development of an Integrated Master Plan (IMP).