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.
The role involves providing expert technical and regulatory consultation on the degradation of implantable medical devices to support premarket submissions. Responsibilities include developing detailed reviews, coordinating with stakeholders, and ensuring compliance with industry standards and FDA requirements.
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.
The Medical Officer serves as an expert clinical reviewer evaluating the safety and efficacy of gastroenterology-related medical devices and clinical studies. Responsibilities include reviewing IDEs, PMAs, and 510(k) submissions and providing expert opinions on post-market compliance and adverse event reports.
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.
Provide expert consulting services to the FDA CDRH to support the review and approval of medical devices. Responsibilities include conducting research, performing data analysis, and developing written reviews for 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.
