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. This position is being recruited based on the Title 21 Pay Table 1, Band A. (GS 11 equivalent).

Duties

Applies scientific knowledge and regulatory understanding to assess data submitted by manufacturers and other stakeholders. Evaluates regulatory submissions, including comprehensive review of manufacturing information, quality date, and labeling materials for compliance with applicable regulations using established methodologies and standards. Contributes to the preparation of regulatory communications with appropriate technical depth and may serve as a technical resource on review teams. Provides analyses and recommendations for high-priority consumer complaints and product complaints related to nutrition, toxic elements, allergens, foodborne illness, dietary supplements, infant formula, etc. Manages and coordinates HFP-related complaints received from consumers, industry, medical professionals, State, Local, Tribal and Territorial (SLTT) authorities, and other Federal agencies and public health partners.

Requirements

Conditions of employment U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date. The candidate selected for this position will serve under a career or career-conditional appointment within the competitive service. Direct Deposit: You will be required to have all federal salary payments electronically deposited into a bank account with a financial institution of your choice. 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. Males born after December 31, 1959, must be registered with the Selective Service. Please go to http://www.sss.gov for more information. Financial Disclosure may be required. Ethics Clearance may be required. 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. 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. Probationary periods are required for new employees appointed to competitive service positions for the first time; or reinstated employees who return after a break in service of 30-days or more and who have not completed a probationary period.

Qualifications

In order to qualify for the Regulatory Scientist position which falls under the 0696 occupational Series, you must meet the following requirements by 11:59 pm EST on 07/14/2026:

Minimal Qualifications Requirements for the Regulatory Scientist RC-696-00 Basic Qualification Requirements:

• Education: A bachelor's degree or higher in quality assurance/management, data science, statistics, computer forensics, epidemiology, pharmacy, public health, engineering, food science, law or regulations, or related healthcare or science field. The degree must be from an accredited program or institution.
• -OR- Have 4 years of comparable regulatory experience or FDA-regulated product lifecycle experience focused on enforcing and/or ensuring compliance with FDA laws and regulations or experience in one or more of the following: Knowledge of the FD&C Act combined with experience in either Current Good Manufacturing Practices (cGMP), or auditing products that the FDA regulates. Interpreting the statute, regulations, guidance, and other quality policies to assess compliance, quality, manufacturing performance, or quality management maturity. Product development, process development, scale-up, or commercial manufacturing. Sterility assurance and microbiological controls.

IN ADDITION TO MEETING THE BASIC REQUIREMENTS OUTLINED ABOVE, APPLICANTS MUST ALSO MEET ONE OF THE FOLLOWING MINIMUM YEARS OF EXPERIENCE REQUIREMENTS FOR THE BAND A.

1. Have a bachelor's degree and also have two (2) years of comparable experience conducting scientific review and evaluation of regulatory submissions and performing analyses of complaints for resolution.
2. Have a master's degree and also have one (1) years of comparable experience conducting scientific review and evaluation of regulatory submissions and performing analyses of complaints for resolution.
3. Have a Doctorate and/or J.D. degree and zero (0) year of comparable experience.
4. Have a MD, DO, DDS, DPM, or DVM degree.
5. Possess four (4) years of comparable experience in conducting scientific review and evaluation of regulatory submissions and performing analyses of complaints for resolution.

NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications. Education Pay careful attention to the Qualifications and Education sections to identify vacancies where a transcript is required. Even if you hold a similar position or are a current employee, you are not exempt from transcript requirements.

Additional Information

Additional Conditions of Employment: Pre-employment physical required: No Drug testing required: No License required: No Mobility agreement required: No Immunization required: No Bargaining Unit: No Telework eligible position: Telework is at the discretion of the supervisor. This position may require financial disclosure reporting and will be subject to FDA's prohibited financial interest regulation. If you are hired, you may be required to divest of certain financial interests. You are advised to seek additional information on this requirement from the hiring official before accepting any job offers. For more information please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics.