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Tunnell Government Services, Inc. · 1 day ago

MEDICAL OFFICER (OTOLARYNGOLOGIST [ENT])

United States

Full-time

Remote

Senior Level, Lead/Staff

15+ years exp

Tunnell Government Services, Inc. is comprised of leading scientists and medical experts, and they are seeking a Medical Officer specializing in Otolaryngology to provide expert consulting services to the FDA Center for Devices and Radiological Health (CDRH). The role involves providing consultation related to medical device reviews, coordinating meetings, conducting research, and executing administrative tasks related to CDRH’s projects.

Biotechnology

Responsibilities

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

Execute other administrative office tasks related to CDRH’s projects

Qualification

Doctor of Medicine (M.D.)Medical licenseOtolaryngology expertiseFDA regulatory knowledgeENT medical devices knowledgeCommunication skillsInterpersonal skills

Required

Doctor of Medicine (M.D. or equivalent) from an accredited medical school in the United States

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 experience

Certification 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 surgery

Knowledge of assessing patients with a variety of ENT disorders such as hearing and balance disorders, head and neck tumors, sino-nasal and voice disorders

Knowledge of diagnostic ENT procedures such as nasopharyngoscopy, otoscopy and ENT surgical procedures

Knowledge of ENT medical devices such as ENT surgical instruments, and implantable ENT devices

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.)