FDA CDRH - Urology SME Position Description The 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 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; write detailed documents and reports; and execute other administrative 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 urology, as relevant to medical devices. Specific expertise involving surgical interventions, and sub-specialization in glaucoma and retinal disease is strongly preferred.
Requirements and Qualifications
- The candidate must possess a Doctor of Medicine (M.D. or equivalent) from an accredited medical school in the United States.
- In 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 seven (7) years of relevant clinical experience
- Board Certification from the American Board of Urology
- Thorough understanding of current clinical practices in urology, including diagnosis and treatment, performance of surgery, and current trends in practice.
- Expert in function and utilization of the full range of medical devices and their accessories used in urological procedures (e.g., peripheral and sacral neurostimulators, surgical mesh for stress urinary incontinence, devices for treatment of voiding dysfunction, prostate cancer treatment devices, etc.).
- Familiarity with FDA medical device regulatory processes 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.
This position is 100% telework.
Please be advised that certain client contracts may outline specific requirements for onsite work. Tunnell employees and/or contractors are expected to comply with all client requirements, including any safety and health protocols.
