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*****THIS ANNOUNCEMENT HAS BEEN EXTENDED DUE TO SYSTEM UNAVAILABILITY****
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) OR YOUR APPLICATION WILL BE CONSIDERED INCOMPLETE.
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.
LOCATION: This position is located in the Food and Drug Administration, Office of Regulatory Affairs, Office of Policy and Risk Management located in Silver Spring, Maryland.
The salary listed in the vacancy announcement includes the geographical locality pay.
TYPE OF POSITION: This position is being filled on a full-time, permanent basis.
PROMOTION POTENTIAL: This is not a career-ladder position; GS-14 is the full performance level.
Additional selections may be made within the same geographical area within FDA.
The incumbent of this Consumer Safety Officer position is a key management official serving in the capacity of a Special Assistant to the Office Director, ORA/Office of Policy and Risk Management, -carrying out diverse responsibilities related to the regulatory review and compliance mission of ORA and the functions of the Office to which assigned, and in performing special assignments related to important and critical priorities of the Office Director. The functions of each ORA/Office of Policy and Risk Management are outlined in the Staff Manual Guide. Acting on the Office Directors priorities, the incumbent performs duties that include resolving a broad range of issues concerning implementing legislation, regulations, policies and/or procedures affecting the Offices program(s). Major duties include:
- Participates in short and long-range planning for the Office, including development of organizational strategies in order to meet the program objectives and mission of the Office and ORA.
- Participates with the Office Director and other management officials in the formulation of program goals, objectives, and broad operations policies. Advances program objectives through analysis and application of sound planning concept.
- Performs unusually difficult and demanding assignments that require occupational expertise and judgment to support particularly complex program activities on a continuing and frequent basis and is responsible for providing the technical and administrative expertise and leadership necessary to resolve matters that are controversial complex and set a general precedent.
- Uses substantive knowledge of regulatory investigative, scientific and/or compliance policies and procedures, analyzes and evaluates aspects of mission-oriented programs of the Office administered by key organizations within the agency. Develops novel ways to resolve problems in meeting established goals, measures, and objectives for program effectiveness.
- Performs special assignments on behalf of the Office Director.
- Is responsible for developing, recommending, and ensuring implementation of ORA regulatory investigative, scientific and/or compliance policies and procedures in order to insure consistency and balance within the functional area(s) of the Office.
- Advises the Office Director and coordinates and provides interpretation and guidance and overall ORA regulatory and operational science policy and issues which cross organizational lines within ORA and the Centers.
- Develops and recommends policy concepts to the Office Director and management staff.
- Participates regularly in top management discussions concerning the formulation of policies and procedures relating to Office functions and operations.
- Drafts or critically reviews documents embodying policy and program proposals and decisions on these products.