In general, these consultants provide consultation related to supporting medical device reviews (EUA, 510(k), PME and De Novo marketing applications, pre-submissions); participate in meetings and teleconferences; coordinate meetings with internal and external stakeholders; develop written reviews and correspondence; perform research; conduct data analysis; write detailed documents and reports; and execute other administrative office tasks related to CDRH's projects. Expert in function and utilization of medical devices commonly used as part of breast imaging radiology (e.g., imaging systems, image-guided intervention devices, localization devices, breast tissue marker devices, contrast agents, AI and advanced imaging software, etc.).