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scientists, medical and technical experts, and human capital and organizational
development professionals. We approach all projects as a team and are committed
to helping our clients transform and quickly achieve strategic goals. If you are
interested in joining an employee-owned company that develops and implements
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FDA CDRH – Ophthalmology – Retinal Disease 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; 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 ophthalmology (expert
in retinal disease), as relevant to medical devices. Specific expertise
involving surgical interventions - advanced micro-surgery, laser therapy,
intravitreal injections, specialized diagnostics.
Requirements and Qualifications
* The candidate must possess a Doctor of Medicine (M.D. or equivalent) from an
accredited medical school in the United States.
* Must have completed a Vitreoretinal / Retinal surgical fellowship
* 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 fifteen (15) years of relevant clinical experience
* Board Certification from and member of the American Board of Ophthalmology
* Ideally, a member of the American Society of Retina Specialists (ASRS) or
affiliated with The Retina Society, American Retina Forum.
* Thorough understanding of current clinical practices in ophthalmology,
including diagnosis and treatment, performance of retinal surgery, and
current trends in practice.
* Expert in function and utilization of ophthalmic medical devices, to include
specific knowledge of non-invasive devices and instruments used for
diagnosis.
* 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.
Must be a US Citizen or full Green Card holder.
Tunnell strives to hire and retain the most qualified talent. We believe that
having employees with different backgrounds and capabilities contributes to the
success of our business. To attract qualified applicants, Tunnell posts to a
wide variety of job sites. All qualified applicants will receive consideration
for employment without regard to race, color, religion, sex, sexual orientation,
gender identity, national origin, disability, or status as a protected veteran.
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.