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 Y (GS-9 equivalent). Responsibilities Office of Medical Device and Radiological Health Inspectorate 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. Requirements Conditions of Employment Qualifications 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 11/08/2024: 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: Education: A 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- A 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- Experience: 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. Desired Experience: Knowledge and skill in applying a professional, concepts, principles, and methodology sufficient to research, analyze, interpret, evaluate, and carry out difficult but conventional assignments; to determine relevancy and use of aesthetic, factual, economic, financial, and professional information; and to prepare and evaluate conventional plans, designs, specifications, and related documentation. Skill in conducting and performing analytical investigations using the scientific method including performance monitoring and quality assurance principles and conducting research by applying accepted and relevant business, marketing, and organizational practices. Ability to recognize serious public health hazards where timeliness and departure from the usual procedures are essential. Demonstrated experience or ability to performs special investigations under detailed instructions, for example, tracing reports of contamination and collecting appropriate samples for laboratory examination. Experience accompanying experienced investigators to gain exposure and interaction with Importer, Brokers, Carriers, and other government agencies such as Customs and Border Protection. 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. TRANSCRIPTS: Positions which are scientific or technical in nature often have very specific educational requirements. You must submit an official transcript, unofficial transcript, or a list including courses, grades earned, completion dates, and quarter and semester hours earned. Education must be accredited by an accrediting institution recognized by the U.S. Department of Education in order for it to be credited towards qualifications. Therefore, provide only the attendance and/or degrees from schools accredited by accrediting institutions recognized by the U.S. Department of Education. If you are using education completed in foreign colleges or universities, see the Foreign Education section below for additional requirements. Electronic Transcript Caution: If you have obtained your transcripts electronically, the file might contain security measures that could prevent our application system from reading the file. Therefore, you should consider asking the institution to provide the file in a non-secured electronic format. Alternatively, you could scan or take a photo of the printed copy of the transcript. If your uploaded transcript cannot be read by our system, you may receive consideration and credit for the information we can access. See the Application Manager Documentation for tips on submitting your paper-based documents. Foreign Education: If you are using education completed in foreign colleges or universities to meet the qualification requirements, you must show that the education credentials have been evaluated by a private organization that specializes in interpretation of foreign education programs and such education has been deemed equivalent to that gained in an accredited U.S. education program; or full credit has been given for the courses at a U.S. accredited college or university. For further information, visit the U.S. Department of Education website for Foreign Education Evaluation. To be acceptable, the foreign credential evaluation must include/describe at a minimum, the following information: (1) The type of education received by the applicant; (2) The level of education in relation to the U.S. education system, and state that its comparability recommendations follow the general guidelines of the International Evaluation Standards Council; (3) The content of the applicant's educational program earned abroad, and the standard obtained; (4) The status of the awarding foreign school's recognition and legitimacy in its home country's education system; and (5) Any other information of interest such as what the evaluation service did to obtain this information, the qualifications of the evaluator, and any indications as to other problems such as forgery. Note: Some positions require the completion of specific courses or a specified number of credit hours. Therefore, the foreign credential evaluation should provide information similar to that of an official transcript, to include a list of the courses taken, quarter and/or semester hours awarded, the cumulative grade point average (GPA), honors received, if any, date degree awarded. Applicants can request an evaluation from a member organization of one of the two national associations of credential evaluation services listed below: National Association of Credential Evaluation Services (NACES) Association of International Credentials Evaluators (AICE) Credential evaluations are not free, and applicants are responsible for the cost of the selected service. For more information about this requirement, please visit the U.S. Department of Education website for Foreign Education Evaluation. Additional Information Additional Conditions of Employment: Pre-employment physical required: No Drug testing required: No License required: Yes, valid driver's license Mobility agreement required: No Immunization required: No Bargaining Unit: Yes, National Treasury Employees Union (NTEU) or American Federation of Government Employees (AFGE) Telework eligible position: Determined upon selection and is at the discretion of the supervisor Financial disclosure statement, OGE-450, required: Please be advised that this position may be subject to FDA's prohibited financial interest regulation and may require the incumbent of this position to divest of certain financial interests. Applicants are advised to seek additional information on this requirement from the hiring official before accepting this position. For more information please visit the FDA Ethics web page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics. Additional Information: Additional selections may be made for similar positions within the commuting area(s) of the locations listed through this vacancy announcement. If you are serving, or have served in the last 5 years (from 11/08/2024) as an Executive Branch political, Schedule C, or Non-career SES appointee, HHS/FDA may be required to obtain approval by the Office of Personnel Management (OPM) prior to beginning employment. You can find out if you have held one of these appointment types by looking at your Standard Form 50s in your Electronic Official Personnel Folder (eOPF), in Section 5 where the legal authorities are listed. If you have served or are currently serving, you must provide a copy of your SF-50, Notification of Personnel Action, documenting this appointment. In addition, you will be required to respond to the question in the assessment and certify your responses to the questionnaire. See Political Appointee FAQ - OPM for more. Applicants selected for this position will be subject to reasonable suspicion and post-accident drug testing upon hiring. To demonstrate commitment to the HHS goal of a drug-free workplace and to set an example for other Federal employees, employees not in a testing designated position may volunteer for unannounced random testing by notifying their Drug-free Federal Workplace Program Point of Contact upon hiring. All requirements must be met by the closing date of this announcement (11/08/2024); only education and experience gained by this date will be considered. You must continue to meet all requirements throughout the entire hiring process.