Physician

The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for protecting and promoting public health by performing essential public health tasks by making sure that medical devices and radiological health products are safe for people in the United States. Within the organization, Physicians of all specialties support the mission and provide critical clinical knowledge to the many offices of CDRH including the Office of Product Evaluation and Quality and the Office of Strategic Partnerships and Technology Innovation. To learn more about the Center and these offices visit our website. As a Physician, you would support the administration of health programs through providing clinical insights or rationale regarding medical services, devices, and/or diagnostic methods. Applicants should possess experience with medical devices and excellent communication skills.

Summary of Duties: Depending on the CDRH office, Physicians may perform some or all of the following duties:

• Provides clinical input on guidance documents that describe FDA’s recommendations for regulatory submissions for various products.
• Serves as a clinical authority in reviewing and evaluating clinical research, findings, scientific properties, analyses, laboratory and clinical behavior and the safety and effectiveness, benefit and risk, and overall impact of various medical device products and technologies submitted to Agency.
• Provides expert clinical guidance in the review of various medical devices, including premarket approval applications, product development protocols, applications for investigational device exemption, premarket notices of intent to market device and inspection reports.
• Completes data analysis on clinical reports and integrates data derived from medical literature, FDA adverse experience reports, material submitted to FDA on similar or analogous substances, results of field surveys by FDA District Offices and consults with authorities in the pertinent fields.
• Secures, exchanges and provides information concerning critical and significant issues/ actions and emerging problems of major concern related to shortages assessment, medical countermeasures, regulatory science and patient science.
• Develops a medical judgment as to the need for corrective action for the protection of the consumer.

Salary: Salary is commensurate with education and experience.

Location: Silver Spring, Maryland

Conditions of Employment:

• Background and/or Security investigation required.
• U.S. citizenship is required.
• This position is subject to strict prohibited financial interest regulations which could restrict the type of financial interest (stock holdings) for the employee, the spouse, and minor children of the employee. Selectee for this position will be required to file a Confidential Disclosure Report (OGE 450) and may require the selectee to obtain clearance from the FDA Division of Ethics and Integrity before a final offer can be made.  For additional information on the prohibited financial interests, please visit the FDA Ethics and Integrity Office.

How to Apply: Prior to applying, please see the following instructions:

• Documents to submit: electronic resume or curriculum vitae, cover letter containing a brief summary of scientific accomplishments, and copy of transcripts
• Compile all applicant documents into one combined document (i.e. Adobe PDF)
• Include Job Reference code “CDRH-21-NMA” in the email subject line.
• Email applicant package/document to CDRHRecruitment@fda.hhs.gov by January 27, 2021.