Regulatory Scientific Reviewer (Regulatory Specialist)
Duties Summary
This position is being filled under a stream-lined hiring authority, Title 21 of the United States Code (21 US Code 379d-3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, Section 3624. The candidate selected for this position will serve under a career or career-conditional appointment and be paid under the provisions of this authority.
Requirements
Qualifications: In order to qualify for the Regulatory Scientific Reviewer (Regulatory Specialist) position which falls under the 0696 occupational Series, you must meet the following requirements by 11:59 pm EST on 07/21/2026:
Minimal Qualifications Requirements for the Regulatory Scientific Reviewer AD-0696-00 Basic Qualification Requirements: A bachelor's or graduate/higher level degree in quality assurance or a related degree 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 product reviewer work. AND/OR Professional experience in regulatory affairs, regulatory review, public health, consumer safety, medical product development, or healthcare policy. Experience includes reviewing submissions for FDA approval, evaluating manufacturing and quality systems, and/or enforcing compliance with FDA laws and standards.
Note: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
IN ADDITION TO MEETING THE BASIC REQUIREMENTS OUTLINED ABOVE, APPLICANTS MUST ALSO MEET ONE OF THE FOLLOWING MINIMUM YEARS OF EXPERIENCE REQUIREMENTS BAND B, RC-0696.
Have a bachelor's degree and have 3 years of comparable experience in regulatory affairs, regulatory review, public health, consumer safety, medical product development, or healthcare policy. Experience includes reviewing submissions for FDA approval, evaluating manufacturing and quality systems, and/or enforcing compliance with FDA laws and standards.
Have a master's degree and have 2 years of comparable experience in regulatory affairs, regulatory review, public health, consumer safety, medical product development, or healthcare policy. Experience includes reviewing submissions for FDA approval, evaluating manufacturing and quality systems, and/or enforcing compliance with FDA laws and standards.
Have a Doctorate and/or J.D. degree and have 1 year of comparable experience in regulatory affairs, regulatory review, public health, consumer safety, medical product development, or healthcare policy. Experience includes reviewing submissions for FDA approval, evaluating manufacturing and quality systems, and/or enforcing compliance with FDA laws and standards.
Have a MD, DO, DDS, DPM, or DVM degree and have 0 years of comparable experience experience in regulatory affairs, regulatory review, public health, consumer safety, medical product development, or healthcare policy. Experience includes reviewing submissions for FDA approval, evaluating manufacturing and quality systems, and/or enforcing compliance with FDA laws and standards.
Have 5 years of comparable experience in regulatory affairs, regulatory review, public health, consumer safety, medical product development, or healthcare policy. Experience includes reviewing submissions for FDA approval, evaluating manufacturing and quality systems, and/or enforcing compliance with FDA laws and standards.
Qualifications
Band B, RC-0696: Have a bachelor's degree and have 3 years of comparable experience in regulatory affairs, regulatory review, public health, consumer safety, medical product development, or healthcare policy. Experience includes reviewing submissions for FDA approval, evaluating manufacturing and quality systems, and/or enforcing compliance with FDA laws and standards.
Band B, RC-0696: Have a master's degree and have 2 years of comparable experience in regulatory affairs, regulatory review, public health, consumer safety, medical product development, or healthcare policy. Experience includes reviewing submissions for FDA approval, evaluating manufacturing and quality systems, and/or enforcing compliance with FDA laws and standards.
Band B, RC-0696: Have a Doctorate and/or J.D. degree and have 1 year of comparable experience in regulatory affairs, regulatory review, public health, consumer safety, medical product development, or healthcare policy. Experience includes reviewing submissions for FDA approval, evaluating manufacturing and quality systems, and/or enforcing compliance with FDA laws and standards.
Band B, RC-0696: Have a MD, DO, DDS, DPM, or DVM degree and have 0 years of comparable experience experience in regulatory affairs, regulatory review, public health, consumer safety, medical product development, or healthcare policy. Experience includes reviewing submissions for FDA approval, evaluating manufacturing and quality systems, and/or enforcing compliance with FDA laws and standards.
Band B, RC-0696: Have 5 years of comparable experience in regulatory affairs, regulatory review, public health, consumer safety, medical product development, or healthcare policy. Experience includes reviewing submissions for FDA approval, evaluating manufacturing and quality systems, and/or enforcing compliance with FDA laws and standards.
Pay
The position is paid under the provisions of Title 21 Pay Table 1, Band B (GS 12 equivalent).
Schedule
The schedule for this position is not specified.
Benefits
The benefits for this position are not specified.