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 Y (GS-9 equivalent).
In order to qualify for the Investigator I position which falls under the 0696 occupational Series, you must meet the following requirements by 11:59 pm EST on 07/14/2025: Basic Qualification Requirements: This Investigator job family covers professional positions that conduct inspections in FDA regulated industries and prepare and submit reports accompanied by supporting evidence documenting violations of the FD&C Act and other laws, regulations, and requirements administered by FDA. The position investigates and/or inspects FDA-regulated industry globally and evaluates compliance with U.S. laws and regulations in order to promote a culture of safety and quality with the objective of preventing unsafe, ineffective and/or defective products from becoming available to patients and consumers or used in clinical trials while facilitating appropriate development of novel products. FDA's enforcement of the laws and regulations protects patients and consumers from products that are impure, unsafe, ineffective, improperly or deceptively labeled or packaged, or in some other way dangerous or defective. Investigators routinely examine products; collect samples; conduct inspections of establishments that design, make, process, hold, or distribute FDA-regulated products; and otherwise gather information and evidence to document objectionable conditions and assess compliance with U.S. law and regulations. Investigators apply critical thinking to evaluate manufacturing processes, design practices, facility and material controls, supply chains, quality management systems, laboratory analyses, and clinical investigation programs to assess compliance with U.S. laws and regulations and to support advancements and innovations. Investigators continuously maintain required certification and credentials; provide internal and external stakeholder outreach, assistance, and education; and may mentor less experienced personnel. These positions require knowledge of various scientific fields such as biochemistry, biology, biotechnology, chemistry, data science, digital health, engineering, epidemiology, food engineering, food processing technologies, food safety, healthcare, medical technology, microbiology, nutrition, pharmaceutical science, pharmacology, public health, quality assurance, and quality management. Education/Experience Requirement: Candidates must meet one of the following: Bachelor's degree 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; AND one (1) year of comparable experience; -OR- Master'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- Without a related degree, candidate must have at least three (3) years of comparable experience. Comparable experience is defined as experience with FDA, a state or federal partner agency, or in an FDA-regulated industry or organization providing investigative or compliance services to an FDA-regulated industry, focused on evaluating or ensuring compliance with FDA or related public health laws and regulations. NOTE: Applicants must submit all relevant transcripts that demonstrate you possess the required education to meet the Basic Qualifications.
Investigator I assignments involve a combination of scientific and regulatory responsibilities which usually call for inspections or investigative approaches to be applied to a wide variety of regulatory functions or scientific evaluations and include sample collections, medical device establishment inspections, and investigations. Incumbent performs analyses and evaluation on data samples and documented information gathered during medical device inspections and investigations to ensure that documentation and practices are in compliance with Federal laws, rules, and regulations. Inspections and Investigations Plans and conducts routine regulatory medical device inspections and limited investigations of various industry establishments; such as manufacturers, re-packers, own label distributors, and importers. Independently carries out routine investigations, inspections, entry review, filer audits and sampling. Upon completion of assignment, prepares concise factual reports reflecting significant observations. Incumbent surveys and follows up with non-compliant industry establishments where violations are clear- cut and seeks voluntary compliance. In situations where compliance is not offered it is enforced through other methods, including administrative action, informational agency meetings and legal court actions. Performs other duties as assigned. Analysis and Reporting Conducts analyses and evaluation on data samples and documented information gathered during medical device inspections, RRAs, and investigations to ensure that documentation and practices comply with Federal laws, rules, and regulations. Documents and organizes required evidence, data, and other information to support violations noted during inspections, RRAs, investigations and sample collections. Interacts with and advises various levels of officials representing the establishments subject to regulatory review. Interacts with and advises various levels of officials representing the establishments subject to regulatory review. Initiates contact with industry officials and manufacturers to obtain basic, incomplete, or missing information on regulatory and scientific documents, to discuss the status of investigations, and to attend meetings and conference calls. Developmental assignments include assisting higher level employees in the review and evaluation of inspection reports of products or establishments submitted by the field for regulatory action consideration. Additional Developmental assignments include providing support (i.e., documenting conversations and noting circumstances) to higher level employees as they interact with industry officials on regulatory issues. Prepares final reports, memoranda, position papers and other written documentation that support investigative findings and recommendations. Reports are developed and, in most instances, accepted with little review of format or content. May be called to testify as an expert witness in administrative hearings and judicial proceedings. Supervisory Responsibilities: This is a non-supervisory role.