Successful candidates will provide expertise and leadership in data integrity and quality systems and have knowledge in interpreting recent national and international quality standards and regulatory developments for quality and clinical affairs. Candidates must be able to develop, interpret and issue policy or guidance on the regulated activities of the research industry, sponsors and monitors, clinical Investigators, institutional review boards, non-clinical laboratories, other Federal agencies, and the general public. The incumbent will serve as a national and international authoritative regulatory review scientist, providing technical leadership and guidance for regulatory, clinical, and quality activities. Candidates must serve as a recognized expert in all aspects of the medical device and radiological health programs. They will have an ability to work collaboratively and have demonstrated ability to make presentations at medical and scientific review panels, advisory committees, formal professional meetings at the national level, and large consumer groups. Additionally they will make final determinations on controversial and sensitive quality management and clinical affairs issues at the forefront of medical technology that have the potential for significant operational, patient, and compliance risk or improvement to drive best practices in quality.
FDA is an equal opportunity employer and encourages applications from a diverse pool of high quality candidates.
This position is located in Silver Spring, MD, convenient to Washington DC, Northern VA, Annapolis, Baltimore and Frederick, MD
Benefits: FDA offers its employees a wide array of benefits. Learn more about employment benefits at www.opm.gov.
Application: Candidates should submit resumes and letters of interest to: CDRHWorkforceManagement@fda.hhs.gov by September 20, 2016.
•U.S.Citizenship is required.
•Time in Grade (TIG) must be met by the closing date of the announcement.
•MUST SUBMIT MOST RECENT SF-50, if applicable
•MUST SUBMIT CLEAN AND CLEAR COPY OF TRANSCRIPTS
•Supervisory Probationary period may be required