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The FDA's Office of Regulatory Affairs is the lead office for all FDA Field activities as well as providing FDA leadership on imports, inspections and enforcement policy. ORA supports FDA Product Centers by inspecting regulated products and manufacturers, conducting sample analysis on regulated products, and reviewing imported products offered for entry into the United States. ORA also develops FDA-wide policy on compliance and enforcement.
Who May Apply: This vacancy is open to current permanent (career/career-conditional appointments) employees of the Food and Drug Administration (FDA) ONLY. Current FDA employees serving under a Schedule-A appointment are eligible for consideration. Title 42 employees not eligible for reinstatement will not be considered.
YOU MUST SUBMIT YOUR SF-50 (Notification of Personnel Action)
Current FDA Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred to the selecting official as Commissioned Corps (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.
The salary listed in the vacancy announcement includes the geographical locality pay.
LOCATION: This position is located in the Food and Drug Administration, Office of Regulatory Affairs, Office of Operations, Office of Medical Products and Tobacco Operations, Division of Medical Products and Tobacco Program Operations, Medical Products and Tobacco Operations Branch in Rockville, MD.
TYPE OF POSITION: This position is being filled on a full-time, permanent basis.
SUPERVISORY PROBATION : First time supervisors/managers are required to serve a one year supervisory/managerial probationary period.
PROMOTION POTENTIAL: This is not a career-ladder position; GS-14 is the full performance level.
Additional selections may be made from this announcement.
The incumbent serves as a first-line supervisor in providing direction and counsel in the implementation of policies and guidelines that form the frame work for management of agency global operational activities including enforcement and import operations, food and feed operations, medical products and tobacco operations, and regulatory science. Major duties include:
- Serves as the focus for investigations and related operations. Directs the activities of staff in order to develop, recommend, and implement policies and procedures needed to carry out functional responsibilities.
- Plans, set priorities, and schedules work within the branch.
- Makes assignments, evaluates performance, counsels employees in work and administrative matters, interviews candidates, and makes recommendations for personnel actions.
- Identifies and resolves investigational problems having national significance.
- Provides advice and consultation during meetings with regulated firms, and in other circumstance.
- Monitors field investigational and inspectional capabilities.
- Evaluates results of the inspectional quality assurance program, and recommends substantive actions or changes.
- Reviews and approves the design, selection, acquisition, and utilization of major investigational and inspectional equipment.
- Is responsible for furthering the goals of equal employment opportunity (EEO) by taking positive steps to assure the accomplishment of affirmative action objectives and by adhering to non-discriminatory employee practices in regard to race, color, religion, sex, national origin, age, or handicap.