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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 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), Office of Regulatory Affairs (ORA) ONLY. Current ORA employees serving under a SCHA 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.
FDA ORA Commissioned Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement. Candidates will be referred to (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.
The salary listed in the vacancy announcement is at the base level. The geographical locality pay will be determined at the time of selection.
This position is located in the Food and Drug Administration, Office of Regulatory Affairs, Office of Medical Products and Tobacco Operations, Division of Medical Products and Tobacco Inspections, Medical Devices and Tobacco Inspection Branch. Duty station and locality pay will be determined upon selection.
THIS IS A TEMPORARY ASSIGNMENT NOT-TO-EXCEED ONE (1) YEAR, BUT MAY BE EXTENDED OR BECOME PERMANENT WITHOUT FURTHER COMPETITION.
**Bonus information: Current GS-13 employees or those who receive a promotion to a GS-13; who have been in a grade for one year and successfully complete organizational goals may receive cash awards at regular intervals up to a total of $10,000 per year.**
If the employee applies and is selected for a one year extension, the incentive will be renewed at the beginning of the extension period.
Additional selections may be made within the same geographical area within FDA-wide.
The incumbent will serve as an expert in medical device inspections as well as inspectional and investigative techniques of medical devices and the evaluation of the good manufacturing practices (GMP's). Major Duties include:
- Carry out inspectional/investigational assignments within the area of medical devices in the international arena.
- Performs as a trouble shooter in the area of medical devices and may be called upon to resolve problems of a national and international scope.
- Conduct and instruct training in specialized areas to Food and Drug Administration Investigators as well as to Investigators from Foreign Governments.
- Interact with Foreign Governments in a coordinating role.
- Assist in compliance cases in the area of expertise.