Investigator I

About the role

This position is filled under a streamlined hiring authority (Title 21 of the United States Code, 21 U.S.C. § 379d‑3a) as amended by the 21st Century Cures Act of 2016, section 3072 and the Consolidated Appropriations Act of 2023, section 3624. The selected candidate will serve under a career or career‑conditional appointment and be paid under the provisions of this authority, based on Title 21 Pay Table 1, Band Y (GS‑9 equivalent).

By joining the Department of Health and Human Services (HHS) you will contribute to an agency that protects the health of every American. HHS is the principal federal agency for safeguarding public health, and the Food and Drug Administration (FDA) ensures that human and animal drugs, medical devices, cosmetics, foods, food additives, medicated feeds, and radiation‑emitting products are safe, effective, and properly labeled.

The role is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Office of Inspections and Investigations (OII), Office of Import Operations (OIO). OII professionals work across a nationwide network of 196 offices, building a public‑health safety net for today’s complex, global regulatory environment.

Responsibilities

• Conduct inspections in FDA‑regulated industries and prepare/submit reports with supporting evidence documenting violations of the FD&C Act and other FDA‑administered laws and regulations.
• Investigate and/or inspect FDA‑regulated industry globally to evaluate compliance with U.S. laws and regulations.
• Promote a culture of safety and quality to prevent unsafe, ineffective, or defective products from reaching patients, consumers, or clinical trials, while facilitating appropriate development of novel products.
• Examine products, collect samples, and conduct inspections of establishments that design, make, process, hold, or distribute FDA‑regulated products.
• Gather information and evidence to document objectionable conditions and assess compliance with U.S. law and regulations.
• Apply critical thinking to evaluate manufacturing processes, design practices, facility and material controls, supply chains, quality management systems, laboratory analyses, and clinical investigation programs.
• Maintain required certifications and credentials; provide internal and external stakeholder outreach, assistance, and education; and may mentor less experienced personnel.
• Utilize knowledge of 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.

Requirements

The position is appointed under the Title 21 streamlined hiring authority, with a career or career‑conditional appointment and pay governed by Title 21 Pay Table 1, Band Y (GS‑9 equivalent).

Qualifications

• Bachelor’s degree in quality assurance/management, data science, statistics, computer forensics, epidemiology, pharmacy, public health, engineering, food science, law or regulations, or a related healthcare or science field (from an accredited program) AND one (1) year of comparable experience; OR
• Master’s degree or higher in any of the fields listed above (from an accredited program); OR
• Without a related degree, at least three (3) years of comparable experience.

Comparable experience is defined as experience with the 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 possession of the required education to meet the basic qualifications.