**HIRING IN MULTIPLE LOCATIONS** **HYBRID JOB**

Miami, FL; Miami Lakes, FL; Memphis, TN; Nashville, TN; Louisville, KY; Savannah, GS; Anchorage, AK; San Diego, CA; Maplewood, MO; Dallas, TX; Houston, TX; Laredo, TX; Falls Church, VA; Jamaica, NY; Houlton, ME; Champlain, NY; Ogdensburg, NY

Associate Investigator & Investigator I

Investigator

Department of Health and Human Services (DHHS)

Food and Drug Administration (FDA)

Office of Regulatory Affairs (ORA)

Office of Import Operations (OIO)

Division of Southwest/Southeast/Northeast/Northern Border/West Coast Imports

Summary:

The position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA) Office of Import Operations (OIO) and being filled under FDA’s Title 21 hiring authority. This hiring authority was passed by Congress in December 2016, to improve FDA’s ability to recruit and retain scientific, technical, and professional experts in certain occupational series that “support the development, review, and regulation of medical products.” The FY23 Omnibus Appropriations Bill expanded the hiring authority to include cross-cutting positions and individuals that support the development, review, and regulation of food and cosmetics in addition to medical products. Both statutes amended the FD&C Act 21 USC. This hiring authority is a streamlined hiring authority, outlined in 21 USC 379d-3a, as amended by the 21st Century Cures Act of 2016, § 3072 and the Consolidated Appropriations Act of 2023, § 3624.

Learn More About This Agency:

Become a part of the Department that touches the lives of every American. At the Department of Health and Human Services (HHS) you can give back to your community, state, and country, by making a difference in the lives of Americans everywhere! HHS is the principal agency for protecting the health of citizens. Join HHS and help to make our world healthier, safer, and better for all Americans. The Food and Drug Administration is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective; that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are safe; and that all such products marketed in the U.S. are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated. The mission of the Office of Regulatory Affairs (ORA) is to protect consumers/patients and enhance public health by ensuring timely access to safe, quality FDA-regulated products. To view our ORA Vision, Mission, and Values please visit: https://www.fda.gov/about-fda/fda-organization/office-regulatory-affairs.

The Office of Regulatory Affairs (ORA) is at the forefront of building a public health safety net

for today’s complex, global regulatory environment. ORA professionals work in a range of

program areas and locations, with 227 offices and 12 laboratories throughout the United

States. As the lead office for all FDA field activities, ORA serves as the agency’s direct

connection with regulated industry through a) inspections of firms and plants producing FDAregulated

products, b) investigations of consumer complaints, emergencies and criminal

activity, c) enforcement of FDA regulations, d) sample collection and analysis, and e) review of

imported products.

The Office of Import Operations (OIO) provides advice and counsel to the Associate

Commissioner for Regulatory Affairs (ACRA) and other Agency senior leaders on import

program operations and activities, and compliance matters. OIO coordinates Agency import

activities with U.S. Customs and Border Protection (CBP), including the development and

institution of joint regulations, procedures, policies, and operations. Coordinates activities with

other Federal agencies and foreign governments through interagency agreements, memoranda

of understanding, and informal working relationships.

Title 21 Pay Table 1, Band W/GS-7 equivalent & Band Y/GS-9 equivalent

Minimum – Band W: $55,924; Band Y: $68,405

Maximum – Band W: $74,155; Band Y: $90,704

Duties

As Associate Investigator (Band W) or Investigator I (Band Y), the incumbent has demonstrated and is recognized for a moderate level of competence in the full range of commodities regulated within the boundaries of an FDA Program such as foods, drugs, medical devices, imports, etc. Assignments involve a combination of scientific and regulatory responsibilities which usually call for a number of atypical inspections, or intensive investigative approaches to be applied to a wide variety of regulatory functions or scientific evaluations; and include the sample collections, establishment inspections, unusual or novel special investigations.

Inspections and Investigations:

• Receives advanced training, through classroom and on-the-job instruction, to provide a more thorough understanding of and exposure to FDA laws and regulations, administrative policies, import operations, and the various methods employed in the conduct of establishment inspections, sample collections, entry review, filer evaluation audits, special investigations, and emergency operations.

• Independently carries out the more common and ordinary import assignments in which the employee has received specific or related training. These assignments vary according to the program to which the employee is assigned but typically are restricted to application of well-defined guidelines to unsophisticated operations to assess the degree of consistency with regulatory practices and efficacy of quality controls.

• Collects samples, conducts field and label exams, and performs other import inspection and investigational activities, review for compliance with import regulations and laws, and records review, etc. Performs necessary tracing and tracking of products and establishes documented jurisdiction over products through established methods. The incumbent must be familiar with sampling schedule guides and billing and shipping procedures of transportation companies.

• Normally accompanies experienced investigators in the conduct of more complex inspections, investigations, field operations and filer evaluation audits. Such assignments involve import practices which require timely and effective interaction with importers, brokers, and carriers as well as other government agencies such as Customs and Border Protection. The primary purpose for such interaction is directed toward data integrity and evaluation of quality controls employed by the regulated industries to prevent importation of violative FDA regulated products. • Assists other experienced investigators in the investigation of unusual consumer complaints, e.g., contaminated products, foodborne outbreaks, etc. which are under FDA jurisdiction. Conducts other investigations where information can be obtained from known sources and is not likely to be deliberately concealed or falsified.

• Performs other duties as assigned.

Analysis and Reporting:

• Obtains, documents, and organizes all required evidence, data, and other information to support inspectional or investigational findings, sample collections, and filer evaluation audits.

• Prepares written reports showing results of the inspection/investigation and submits to the supervisor or higher graded investigator for review and evaluation.

• Accompanies experienced investigators to gain exposure in providing evidence to support professional testimony in court cases in support of legal action.

Supervisory Responsibilities: This is a non-supervisory role.

How to Apply

Applications will be accepted by all qualified applicants. United States Citizenship is required. Applicants must submit a letter of interest addressing experience in the major duties and responsibilities of the position, a detailed current resume, and college transcript(s) showing degree was awarded (with foreign credentials evaluation if applicable). A diploma will not be accepted as part of your application. All required materials should be sent to: ORAInvestigatorHiring@fda.hhs.gov. Applications will be accepted through November 5, 2024, or until all positions have been filled.

IMPORTANT: Applicants must show this job reference ID in the email subject line: 8-Assoc. Inv/Inv I-OIO-name of preferred location(s).

NOTE: It is your responsibility to ensure the job reference ID is noted in the subject line and the appropriate required documentation is submitted prior to the closing date for your application to be considered.

Announcement Contact

For questions regarding this T21 position, please contact ORAInvestigatorHiring@fda.hhs.gov. and include the following job reference ID in the subject line: 8-Assoc. Inv/Inv I-OIO-Q.