This Senior Investigator II (Foreign) position is with Food and Drug Administration (Department of Health and Human Services) in Nogales, AZ.
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).
Key duties:
• Inspect foreign medical device and radiological health establishments for which CDRH has regulatory responsibility.
• Collect samples for analysis, performing field examinations, and preparing reports.
• Prepare and provide evidence of investigational support to Headquarters, other Divisions and CDRH, as needed.
• Advise OII and OMDRHI on emerging inspectional, scientific, and regulatory issues related to medical device and radiological health products.
• Provides counsel and training regarding inspectional techniques and technical developments to other Federal agencies, foreign counterpart agencies, and to industry, as appropriate.
• Advise on inspectional and investigative techniques in the area of medical products and exclusively conducts international inspections in the areas of medical devices and radiological health.
• Assume the primary responsibility for carrying out approximately 18 to 20 foreign medical device inspections within a calendar year.
• Serve as a technical resource within their area of expertise, is often consulted in matters pertaining to the promulgating of regulations and is required to review drafts of and to comment on whether such proposals are feasible or desirable.
• Perform other duties as assigned.
Qualifications:
In order to qualify for the Senior Investigator II (Foreign) position which falls under the 0696 occupational Series, you must meet the following requirements by 11:59 pm EST on 10/09/2026: 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 four (4) years 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 AND three (3) year of comparable experience; -OR- Doctorate 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; MD/DO/DDS/DPM/DVM-OR- Without a related degree, candidate must have at least six (6) 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.
View the full announcement and apply on USAJOBS.gov.