State Licensed Retinal Specialist

Job Summary

Providing expert consulting services, the part-time State Licensed Retinal Specialist will support the FDA CDRH with regulatory responsibilities related to medical devices, focusing on retinal disease and surgical interventions while working remotely.

Key responsibilities

• Consult on medical device reviews, including EUA, 510(k), PME, and De Novo marketing applications
• Participate in meetings and teleconferences, coordinating with internal and external stakeholders
• Conduct research, perform data analysis, and write detailed documents and reports related to CDRH projects

Required qualifications

• Doctor of Medicine (M.D. or equivalent) from an accredited medical school in the United States
• Completion of a Vitroretinal/Retinal surgical fellowship
• Current, active, full, and unrestricted medical license or registration as a Physician
• At least fifteen (15) years of relevant clinical experience
• Board Certification from the American Board of Ophthalmology