Washington, DC13 days ago
li>Expert in function and utilization of medical devices commonly used as part of surgical oncology (e.g., advanced energy and resection devices [electrosurgical units, ultrasonic scalpels, argon beam coagulators], minimally invasive and robotic platforms [robotic-assisted surgery systems, laparoscopes and thoracoscopes], localization and navigation devices [tumor localization seeds, intraoperative ultrasound], tumor ablation systems [radiofrequency ablation and microwave ablation, cryoablation systems, irreversible electroporation], lymph node mapping systems [gamma probes, near-infrared fluorescence imaging], intraoperative therapy devices [hyperthermic intraperitoneal chemotherapy pumps, intraoperative radiation therapy systems]). 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.