Regulatory Systems Manager

About the Position: MRDC is now part of the Defense Health Agency (DHA) Research & Development (R&D). We are the medical materiel developer, with responsibility for medical research, development and acquisition. Our expertise in these critical areas helps establish and maintain the capabilities the military needs to remain ready and lethal on the battlefield. Please visit our website https://mrdc.health.mil/ This is a Direct Hire Solicitation

Ensure the Food and Drug Administration (FDA) regulated IT systems, programs, and processes comply with Federal, Defense Health Agency (DHA) and Medical Research and Development Command (MRDC) regulations and policies.

Manage user accounts, training, and issues for Office of Regulated Activities (ORA) regulatory systems.

Write, edit, and manage standard operating procedures (SOPs) and policies to ensure that ORA’s regulated and quality systems stay up to date and compliant with current regulations.

Asses current and potential FDA regulated systems, processes, and policies for compliance and effectiveness using documented, metric-based, approaches.

Oversee creation, editing, and submission of electronic common technical document (eCTD) compliant documents and manage our eCTD templates.

Perform and oversee regulatory compliance and quality reviews of submissions to the FDA.

Build and oversee a comprehensive quality management system at ORA.

Work with ORA staff to identify and mitigate quality and regulated IT systems risks.