Ophthalmology - Retinal Specialist SME

Responsibilities: Provide expert consulting services to the FDA CDRH to support the review and approval of medical devices related to retinal disease. Responsibilities include conducting research, performing data analysis, and developing written reviews and correspondence for various marketing applications.

Requirements: Requires an M.D. with a Vitroretinal surgical fellowship, board certification from the American Board of Ophthalmology, and at least 15 years of relevant clinical experience. Candidates must hold an active, unrestricted medical license and be a US citizen or Green Card holder.

Key skills: Retinal Disease Expertise, Advanced Micro-surgery, Laser Therapy, Intravitreal Injections, Specialized Diagnostics, Medical Device Regulation, Clinical Data Analysis, Technical Writing, Ophthalmic Device Utilization, Regulatory Review, Interpersonal Communication, Stakeholder Coordination

Keywords: Ophthalmology, Retinal Specialist, FDA, CDRH, Medical Devices, EUA, 510(k), PME, De Novo, Pre-submissions, Vitroretinal Surgery, American Board of Ophthalmology, ASRS, The Retina Society, American Retina Forum, Clinical Medicine, Regulatory Affairs, Non-invasive Devices, Telework