Regulatory Specialist
What you'd do
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 C. (GS-13 equivalent)
Major duties
Plans and carries out assignments, resolves most technical conflicts, and leads multidisciplinary discussions to address high-impact, controversial, or precedent-setting issues within their designated area of expertise. Analyze complex data and guidelines or criteria for scientific review and approval for a class of blood establishment computer software (BECS) and immunohematology assays. Identify risks, gaps, trends, and review or coordination of review of important precedent setting scientific issues which establish policy for subsequent reviews of similar products. Interpreting regulatory requirements, evaluating compliance with applicable legal and procedural standards, and providing expert guidance on the development and implementation of regulatory frameworks across multidisciplinary program areas. Assumes responsibility for a team effort to resolve complex or regulatory significance of issues and problems relating to the area of assignment. Possess comprehensive critique of data, recommendations for additional studies, gathering of pertinent scientific information and written evaluations and professional inclusions.
What you need to qualify
In order to qualify for the Regulatory Specialist position which falls under the 0696 occupational Series, you must meet the following requirements by 11:59 pm EST on 07/17/2026: 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-- Experience: 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. 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. Have a bachelor's degree and have 4 years of comparable experience manufacturing of foods, biologics, drugs or devices in compliance with CGMP; clean room facility design and/or operations; equipment and process design and validation; and/or manufacturing process deviation investigations and knowledge of laws, regulations, policies and guidance used in regulating foods, biologics, drugs or devices and knowledge of those governing manufacturing procedures and product approval or licensing. OR Have a master's degree and have 3 years of comparable experience manufacturing of foods, biologics, drugs or devices in compliance with CGMP; clean room facility design and/or operations; equipment and process design and validation; and/or manufacturing process deviation investigations and knowledge of laws, regulations, policies and guidance used in regulating foods, biologics, drugs or devices and knowledge of those governing manufacturing procedures and product approval or licensing. OR Have a Doctorate and/or J.D. degree and have 1 years of comparable experience manufacturing of foods, biologics, drugs or devices in compliance with CGMP; clean room facility design and/or operations; equipment and process design and validation; and/or manufacturing process deviation investigations and knowledge of laws, regulations, policies and guidance used in regulating foods, biologics, drugs or devices and knowledge of those governing manufacturing procedures and product approval or licensing. OR Have a MD, DO, DDS, DPM, or DVM degree and have 0 years of comparable experience manufacturing of foods, biologics, drugs or devices in compliance with CGMP; clean room facility design and/or operations; equipment and process design and validation; and/or manufacturing process deviation investigations and knowledge of laws, regulations, policies and guidance used in regulating foods, biologics, drugs or devices and knowledge of those governing manufacturing procedures and product approval or licensing. OR Have 6 years of comparable experience manufacturing of foods, biologics, drugs or devices in compliance with CGMP; clean room facility design and/or operations; equipment and process design and validation; and/or manufacturing process deviation investigations and knowledge of laws, regulations, policies and guidance used in regulating foods, biologics, drugs or devices and knowledge of those governing manufacturing procedures and product approval or licensing.
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