Ophthalmology - Retinal Specialist 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 radiation-emitting products. This role involves providing consultation related to medical device reviews, 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. The candidate will offer expertise in clinical medicine and ophthalmology, specifically in retinal disease, as it pertains to medical devices, including surgical interventions, advanced micro-surgery, laser therapy, intravitreal injections, and specialized diagnostics.

Requirements

Doctor of Medicine (M.D. or equivalent) from an accredited medical school in the United States
Completed a Vitroretinal / Retinal surgical fellowship
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
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
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

Ideally, a member of the American Society of Retina Specialists (ASRS) or affiliated with The Retina Society, American Retina Forum
Familiarity with FDA medical device regulatory processes 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
Provide expert consulting services to assist the CDRH with their regulatory responsibilities
Offer specific expertise and training in clinical medicine and ophthalmology (expert in retinal disease), as relevant to medical devices
Provide expertise involving surgical interventions - advanced micro-surgery, laser therapy, intravitreal injections, specialized diagnostics