Washington, DC23 days ago
p>Tunnell Government Services, Inc. is providing professional and scientific services to the CDRH with expert consultants with scientific expertise in the regulation and approval and of medical devices.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 orthopedic surgery (e.g., permanent and temporary implants [prostheses, fixation devices, osteobiologics], surgical instruments (e.g., bone cutting tools, preparation tools, soft tissue tools), enabling and smart technologies [robotic-assisted platforms, smart implants, AR/VR guidance, 3-D custom implants], and external fixation) to include specific knowledge of non-invasive devices and instruments used for diagnosis; invasive devices, such as implantable devices; and surgical systems.