The engineer will perform technical and regulatory reviews of medical devices to support lifecycle management and regulatory submissions. They will also coordinate with FDA stakeholders to ensure consistent application of regulatory standards and document recommendations for device classification.
Provide expert consulting services to the FDA Center for Devices and Radiological Health regarding medical device reviews and regulatory responsibilities. Conduct data analysis, develop written reviews, and coordinate with stakeholders to support the approval of medical devices.
Conduct comprehensive technical and scientific reviews of medical device submissions, including 510(k), PMA, and De Novo applications. Provide subject matter expertise in ultrasound physics and imaging performance while supporting postmarket surveillance and regulatory compliance activities.
Provide expert consulting services to the FDA CDRH by supporting medical device reviews, including EUA, 510(k), and De Novo marketing applications. Coordinate with stakeholders, perform research, conduct data analysis, and develop detailed written reviews and reports.
The candidate will serve as a technical authority providing expert consultation on veterinary medicine and animal models for human medical device regulatory reviews. Responsibilities include assessing technical data, participating in sponsor meetings, and assisting review teams with documentation and data analysis.
Provide expert mechanical engineering consultation for the regulatory review of cardiovascular medical devices, focusing on durability, fatigue, and structural integrity. Evaluate test reports, computational models, and verification data to ensure compliance with FDA standards and safety requirements.
The contractor will conduct technical reviews of medical device regulatory submissions and provide expert support for postmarket compliance activities. They will also evaluate radiation oncology and imaging technologies for safety, effectiveness, and clinical application.
Provide strategic regulatory expertise and technical guidance for the Strategic Active Pharmaceutical Ingredients Reserve (SAPIR) initiative. Oversee FDA-regulated small-molecule drug products, focusing on submission strategies, CMC development, and manufacturing compliance.
Conduct scientific and regulatory reviews to evaluate the safety and effectiveness of new ophthalmic devices for the FDA. Prepare comprehensive memos and recommendations regarding submission clearance, approval, or disapproval for various medical device actions.
Provide expert consulting services to the FDA CDRH to support the review and approval of medical devices related to retinal disease. Responsibilities include conducting research, performing data analysis, and developing written reviews and correspondence for various marketing applications.
The consultant will provide expert scientific and clinical support for the FDA Center for Devices and Radiological Health regarding medical device reviews and marketing applications. Responsibilities include performing research, conducting data analysis, writing detailed reports, and coordinating with internal and external stakeholders.
