MEDICAL OFFICER (OTOLARYNGOLOGIST [ENT])

FDA CDRH – Medical Officer (Otolaryngologist [ENT]) SME Position DescriptionThe mission of the FDA Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products.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 general, these consultants provide consultation related to supporting medical device reviews (EUA, 510(k), PMA, HDE and De Novo marketing applications, Pre-submissions, Investigational Device Exemptions, Recalls); 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.Tunnell is seeking a candidate to provide expert consulting services to assist the CDRH with their regulatory responsibilities. This candidate should possess specific expertise and training in clinical medicine and otolaryngology, as relevant to medical devices.Requirements and QualificationsThe candidate must possess a Doctor of Medicine (M.D. or equivalent) from an accredited medical school in the United addition, the candidate must possess a current, active, full, and unrestricted medical license or registration as a Physician to practice medicine in a State, District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States.At least fifteen (15) years of relevant clinical experienceCertification from a U.S. relevant specialty board organization, e.g., the American Board of Otolaryngology – Head and Neck Surgery, etc.Thorough understanding of current clinical practices in otolaryngology, including diagnosis and treatment, and current/emerging trends in practice.Knowledge of general ENT anatomy and ENT surgeryKnowledge of assessing patients with a variety of ENT disorders such as hearing and balance disorders, head and neck tumors, sino-nasal and voice disordersKnowledge of diagnostic ENT procedures such as nasopharyngoscopy, otoscopy and ENT surgical proceduresKnowledge of ENT medical devices such as ENT surgical instruments, and implantable ENT devicesFamiliarity with FDA medical device regulatory processes, regulations (e.g., 21 CFR Part 874 – Ear, Nose, and Throat Devices), and guidances is preferred.Ability to communicate well with others using excellent written and verbal communication skills.Excellent interpersonal skills, with the ability to effectively work both independently and within a team of technical personnel (i.e., engineers, statisticians, biologists, etc.).This position is 100% telework. #J-18808-Ljbffr

Created: 2025-10-08