Regulatory Affairs Subject Matter Expert 2

Odyssey Systems Consulting Group, Ltd.•Silver Spring, MD

7d•Onsite

About The Position

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

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.