State Licensed Gastroenterologist

Job Summary

Providing expert consulting services, the part-time State Licensed Gastroenterologist will evaluate the safety and efficacy of medical devices, review clinical studies, and offer recommendations to the FDA's Center for Devices and Radiological Health while working remotely.

Key responsibilities

• Review and analyze pre- and post-market submissions, including IDEs, PMAs, and 510(k)s
• Provide expert clinical judgment related to post-market compliance reviews and adverse event reports
• Offer expert opinions on medical devices and address complex regulatory questions related to gastroenterology

Required qualifications

• Doctor of Medicine (M.D. or equivalent) from an accredited medical school in the United States
• Current, active, full, and unrestricted medical license to practice in a U.S. jurisdiction
• At least 15 years of relevant clinical experience in gastroenterology
• Certification from a relevant U.S. specialty board organization in Internal Medicine and Gastroenterology
• Thorough understanding of current clinical practices and emerging trends in gastroenterology