Medical Officer - Neurology SME

Tunnell Government Services • Bethesda, MD

2d • Remote

About The Position

Tunnell Government Services, Inc. is seeking a candidate to provide expert consulting services to assist the FDA Center for Devices and Radiological Health (CDRH) with their regulatory responsibilities. The CDRH's mission is to protect and promote public health by ensuring timely access to safe, effective, and high-quality medical devices and safe radiation-emitting products. This role involves supporting medical device reviews (EUA, 510(k), PME and De Novo marketing applications, Pre-submissions), participating in meetings, coordinating with stakeholders, developing written reviews and correspondence, performing research, conducting data analysis, writing detailed documents and reports, and executing other administrative tasks related to CDRH's projects. The candidate should possess specific expertise and training in clinical medicine and neurology, relevant to medical devices used to diagnose, treat, and monitor neurological conditions.

Requirements

• 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 seven (7) years of relevant clinical experience
• Certification from a U.S. relevant specialty board organization, e.g., American Board of Psychiatry and Neurology, etc.
• Thorough understanding of current clinical practices in neurology, including diagnosis and treatment, and current/emerging trends in practice
• 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
• Must be a US Citizen or full Green Card holder

Nice To Haves

• Preferred experience with, or interest in neurological medical devices (e.g., deep brain stimulators, neurostimulators, neurointerventional devices, or exoskeletons for rehabilitation, etc.), to include knowledge of non-invasive devices and instruments used for diagnosis; invasive devices, such as implantable devices; and surgical systems.
• Familiarity with FDA medical device regulatory processes, regulations (e.g., 21 CFR Part 882 -- Neurological Devices), and guidances is preferred.

Responsibilities

• 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
• Execute other administrative office tasks related to CDRH’s projects

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Ph.D. or professional degree