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).

Duties

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

• 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.
• One-year probationary period may be required.
• 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.
• This position requires the incumbent to have the following current license and/or certification: Must possess a valid driver’s license to drive a government or privately owned motor vehicle.
• Position requires occasional lifting of heavy objects up to 50 lbs and may require work to be performed in extreme environmental conditions such as dust, cold, hot, noise, etc., extended periods of time.
• Travel approximately 25-50 percent of the time, which may require the investigator to be away from the duty station for up to two to three weeks at a time.
• Position may include shift work and/or weekend work.

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:

1. National Association of Credential Evaluation Services (NACES)
2. 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.

Contacts

• Address FDA Center Office of Inspection and Investigation 10903 New Hampshire Ave Silver Spring, MD 20852 US
• Name: FDA Applicant Help Desk
• Phone: 866-807-3742
• Email: [email protected]