FDA Office of Regulatory Affairs
This Direct-Hire position is in the Food and Drug Administration, with multiple locations throughout the U.S. and its territories.
- Monitors and/or manages compliance initiatives and serves as FDA representative on investigations.
- Reviews and evaluates evidence and findings to determine compliance with FDA-enforced laws and regulations.
- Prepares correspondence stating Agency concerns in regulatory reviews.
50% or less – You may be expected to travel for this position.
Conditions of Employment
- This position may be subject to completion of a 1-year probationary period (unless you have already satisfied this obligation).
- Citizenship Requirement: You must be a U.S. Citizen or U.S. National to be considered for this advertisement. Foreign nationals or legal permanent residents are not eligible for consideration.
- Direct Deposit: All Federal employees are required to have Federal salary payments made by direct deposit to a financial institution of their choosing.
- Background Investigation Requirement: All employees must pass a security investigation. Failing to pass the background check may be grounds for removal or legal action. If hired, you may be subject to additional investigations at a later time.
- FDA participates in e-Verify: All new hires must complete the I-9 form; this information will be processed through e-Verify to determine your employment eligibility. If a discrepancy arises, you must take affirmative steps to resolve the matter.
- Selective Service Registration: All applicants born male, on (or after) 12/31/1959, must be registered with the Selective Service System OR have an approved exemption. Visit www.SSS.gov for more info.
- Additional selections may be made from this vacancy, within the same geographical area, by other organizational elements from within FDA, through shared corporate recruiting activities. Your application may be shown to multiple hiring offices.
- You may be asked to provide additional information at a later time. All interviews requests and selection decisions are at the full discretion of the hiring office.
- Certification of Accuracy: All information concerning eligibility and qualification is subject to investigation and verification. False representation may be grounds for non-consideration, non-selection, or appropriate legal action.
- Position requires occasional lifting of heavy objects up to 50 lbs and may require work to be performed in extreme environmental conditions such as dust, cold, hot, noise, etc…, for extended periods of time.
Applicants must have successfully completed one of the following (A or B):
A. Bachelor's or graduate/higher level degree in quality assurance or a related degree that included at least 30 semester hours in one or a combination of the following: consumer laws, biological sciences, food science, chemistry, pharmacy, physical sciences, food technology, nutrition, medical science, engineering, epidemiology, veterinary medical science, legal investigations, law enforcement, or related scientific fields that provided knowledge directly related to consumer safety officer work. The 30 semester hours may include up to 8 semester hours in statistics, or course work that included the principles, theory, or practical application of computers or computer programming; -OR-
B. Combination of education and experience–courses consisting of at least 30 semester hours in the fields of study described in paragraph A above, plus appropriate experience or additional education.
MINIMUM QUALIFICATIONS REQUIREMENTS:
You must possess one year (52-weeks) of specialized experience, equivalent to at least the next lower grade level (GS-07) in the Federal service. Such experience includes: conducting routine inspections; interpreting and evaluating scientific data; developing and drafting reports on technical study findings and compliance documents; -OR-
Master's or equivalent graduate degree or two full years of progressively higher level graduate education leading to such a degree in a field related to the position to be filled; -OR-
Combination of specialized experience and graduate level education in a field related to the duties of this position that meets 100% of the qualification requirements for this position.
A career with the U.S. Government provides employees with a comprehensive benefits package. As a federal employee, you and your family will have access to a range of benefits that are designed to make your federal career very rewarding.