The Food and Drug Administration - Protecting and Promoting YourHealth
Help protect public health by joining the FDA's Center for Devices & Radiological Health (CDRH). From reviewing applications for innovative medical devices to educating industry on relevant policies and regulations to providing accurate, science-based health information to the public, CDRH is at the forefront in ensuring the safety, efficacy, and security of the medical devices and radiation-emitting products that millions of Americans use daily.
This position is located at the FDA, CDRH, Office of Surveillance and Biometrics.
This vacancy is also being announced concurrently with vacancy announcement HHS-FDA-CDRH-MP-14-1018692 under merit promotion procedures. Please review that announcement to see if you are eligible for consideration under merit promotion procedures. NOTE: Applicants must apply separately for each announcement in order to be considered.
One or more positions may be filled using this vacancy announcement.
As an Interdisciplinary Engineer, you will provide professional support in the review, analysis, and evaluation of scientific data related to enforcement of the electronic product radiation control and medical device provisions of the Food, Drug and Cosmetics Act. Duties include:
Understanding the radiation-emitting electronic product and radiology device industry, current state of technology, expected conditions of use and risks to health for these products and devices;
Serving as a reviewer of a variety of medical device pre-market submissions, such as pre-market notifications, pre-market approval applications, and investigational device exemptions;
Evaluating safety of electronic products and medical devices over their useful life, monitoring postmarket performance and compliance with regulatory requirements;
Participating as a member of a team of experts to develop general agency-wide guidelines applicable to the regulation of electronic products and medical devices; and
Exchanging scientific and regulatory information with industry, academic and professional stakeholders in order to promote device safety and compliance, inform decision-making and advance common public health goals.