Regulatory Affairs Scientist (Devices)

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

Develop and implement comprehensive regulatory affairs strategies for advanced 'tech base' medical devices and diagnostic products to ensure mission-critical compliance from early development

Establish and maintain Quality Management Systems specifically tailored for the lifecycle of advanced medical diagnostics and early-stage technological innovations

Lead Medical Devices branch personnel, providing professional mentorship while managing high-priority project portfolios to meet operational milestones

Direct all Food and Drug Administration-regulated activities across the development pipeline, ensuring organizational adherence to federal statutes and agency mandates

Oversee the execution of nonclinical and clinical studies, ensuring all research activities strictly adhere to Good Clinical Practices and internal protocols

Manage manufacturing and testing operations to ensure full compliance with Good Manufacturing Practices and Quality Management System Regulations

Align product development plans with both pre-market and post-market Food Drug Administration requirements to facilitate efficient device clearance, approval, and long-term surveillance

Execute medical device classification processes and conduct risk assessments to categorize Significant Risk and Non-significant Risk research studies

Lead the preparation and strategic management of regulatory submissions, including Investigational Device Exemptions, premarket notifications, Deovo and Premarket approval

Perform expert regulatory reviews of complex Food and Drug Administration submissions, including Pre-Submissions, Premarket Approvals, and Emergency Use Authorization requests