The Food and Drug Administration - Protecting and Promoting Your Health
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.
One or more positions may be filled using this vacancy announcement.
As a Scientist in the Office of Device Evaluation, you will serve as the senior level reviewer of data in your scientific specialty field in order to determine the safety and efficacy of medical devices. Duties include:
· Reviewing scientific data submitted in support of a variety of medical device submissions (e.g. premarket applications, product development protocols, applications for investigational device exemptions, etc.) to determine its accuracy and sufficiency;
· Reviewing research protocols used to evaluate medical devices and recommending new or modified methods for testing and data analysis;
· Writing and evaluating guidelines concerning data submissions for medical devices and their marketing;
· Making presentation to the medical/scientific panel members on the FDA Advisory Committee responsible for the classification and premarket review of medical devices; and
· Drafting a variety of reports and summaries on the safety and effectiveness of devices submitted in a premarket approval application