Serve as the Epidemiologist, planning and conducting multiple scientific reviews and research studies focused on the safety and effectiveness of medical device products;
Plan and carry-out quality control programs and select statistical and epidemiologic methods for use in quality control analysis.
Ensure the reliability and consistency of the data while measuring data limitations;
Write reports on studies for distribution to health professionals, other government agencies, industry and/or the public which may include submission for publication in professional peer reviewed journals;
Serve as a consultant on a variety of epidemiologic issues related to the mission of the Center for Devices and Radiological Health (CDRH);
Assist members of a team presenting epidemiologic data at Food and Drug Administration (FDA) advisory committee meetings and professional meetings and conferences where subject under consideration is related to the projects.
Analyzing epidemiologic public health issues involving post-market medical devices and/or radiological products; and synthesizing epidemiologic evidence to interpret technical scientific data as a part of epidemiologic studies.
In addition, the epidemiologist may participate on a number of postmarket activities, such as medical device report analyses, allegations, recalls, establishment inspection reports, and HDE/PMA manufacturing reviews.
Bachelor's or graduate/higher level degree: major study in an academic field related to the medical field, health sciences or allied sciences appropriate to the work of the position. This degree must be from an educational program from an accrediting body recognized by the U.S. Department of Education (external link) at the time the degree was obtained.
FDA IS AN EQUAL OPPORTUNITY EMPLOYER AND HAS A SMOKE FREE ENVIRONMENT. TO QUALIFY FOR EMPLOYMENT, ALL APPLICANTS MUST MEET ALL CIVIL SERVICE OR COMMISSIONED CORPS REQUIREMENTS INCLUDING U.S. CITIZENSHIP.
Internal Number: OHT606011213
About U.S. Food and Drug Administration
ODE is responsible for the program areas through which medical devices are evaluated or cleared for clinical trials and marketing. This page provides summary information about the major programs administered by ODE and includes a brief description of the premarket approval, product development protocol, humanitarian device exemption, investigational device exemption, and premarket notification programs.