Version: 11/2021

Title 21 Vacancy Announcement

Department of Health and Human Services (HHS)

Food and Drug Administration (FDA)

Office of Regulatory Affairs (ORA)

Office of Import Operations (OIO)

Investigator II

Application Period: October 10, 2023 – April 10, 2024

Area of Consideration: United States Citizenship is required. You must be a U.S. Citizen or U.S. 

National. Foreign nationals or legal permanent residents are not eligible for consideration.

Position: Investigator II Series: AD-0696

Location(s): Multiple vacancies in the following 

locations: Nogales, AZ; Tempe, AZ; Alameda, CA; El 

Segundo, CA; Ontario, CA; San Diego, CA; Stockton, 

CA; Sacramento, CA; Fort Lauderdale, FL; Miami, FL; 

Miami Lakes, FL; Savannah, GA; Honolulu, HI; 

Eastport, ID; Itasca, IL; Metairie, LA; Stoneham, MA; 

Baltimore, MD; Houlton, ME; Detroit, MI; 

Maplewood, MO; Sweetgrass, MT; Pembina, ND; 

Newark, NJ; Las Vegas, NV; Alexandria Bay, NY; 

Buffalo, NY; Champlain, NY; Jamaica, NY; Ogdensburg, 

NY; Brunswick, OH; Portland, OR; Philadelphia, PA; 

Memphis, TN; San Juan, PR; Dallas, TX; Houston, TX; 

Laredo, TX; Portsmouth, VA; Highgate Springs, VT; 

Blaine, WA; Seattle, WA

Work Schedule: Full Time 

Salary: Starting at $82,764 (Band A)

 Starting at $99,200 (Band B)

Title 21 Band(s): Band A, Band B, Table 1 Full Performance Band Level: Band B

Travel Requirements: Up to 25% travel.

Bargaining Unit: This is a bargaining unit position.

Hiring Incentives: Incentives may be authorized; however, this is contingent upon funds 

availability. If authorized, certain incentives will require you to sign a service agreement to 

remain in the Federal government for a period of up to 4 years. Note: This statement does not 

imply nor guarantee an incentive will be offered and paid. Incentives may include recruitment 

or relocation incentives in accordance with the FDA, Title 21 Policy.
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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. 

Introduction

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 United States are adequately, truthfully and informatively labeled and safely 

and properly stored, transported, manufactured packaged and regulated. FDA’s programs are 

national in scope and effect, and the agency’s activities have a direct and significant impact on 

multi-billion-dollar industries, in addition to protecting the health and safety of American 

Consumers. The work of the Agency is carried out by a staff of more than 18,000 scientists, 

physicians, regulatory and other personnel stationed throughout the United States.

The mission of the Office of Regulatory Affairs 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/fdaorganization/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. 
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Duties/Responsibilities

The Investigator II has demonstrated and is recognized for a high level of competence in the full 

range of establishments regulated within the OIO program such as: inspections and 

investigation of domestic imports and foreign facilities; investigations supporting admissibility 

decisions for all FDA-regulated commodities imported into the U.S. including hands-on product 

reviews/sampling and assessment of compliance factors. These types of inspections and 

investigations will account for a level greater than 90% of the Investigator’s

inspectional/investigative work.

Assignments involve a combination of scientific and regulatory responsibilities which usually 

call for several atypical inspectional or intensive investigative approaches to be applied to a 

wide variety of regulatory functions or scientific evaluations; and include sample collections, 

product examinations, establishment inspections, unusual or novel special investigations and 

conducting objective surveys and emergency activities within the assigned area of 

responsibility. The Investigator II will also perform international inspections.

Inspections and Investigations:

• Independently plans and conducts regulatory inspections and in-depth investigations 

of various imported products to include sample collections, field examinations, label 

examinations, filer evaluations, and emergency activities.

• Independently plans and conducts regulatory establishment inspections of importers 

to ensure compliance with statutory and regulatory requirements such as Foreign 

Supplier Verification Programs inspections and Seafood HACCP Importer Verification 

inspections.

• Assignments are frequently complicated by a variety of diverse imported products, 

ingredients, and additives; highly specialized and sophisticated medical products; 

complex labeling; record documentation; or uncooperative management.

• Incumbent conducts inspections and investigations to follow up with non-compliant 

industry establishments on previously noted violations. In situations where 

compliance is not offered, it is enforced through the detention and refusal process, 

responding to emergency import situations, warning letters, increased screening, 

agency meetings and legal court actions. 

• The Investigator II may perform import entry review requiring decisions to release or 

detain FDA regulated commodities based on document review, product examination 

and/or sampling following established guidance. The entry reviewer may also issue 

routine assignments to inspectors and investigators for field examination and 

sampling.

• Performs routine audits of entry filers (those firms submitting information when 

presenting FDA regulated products for entry into the U.S.) to assure proper data 

submission to FDA.

• Performs other duties as assigned.
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Analysis and Reporting:

• Incumbent performs analyses and evaluation on import history and data samples and 

documented information gathered during inspections and investigations to ensure 

that documentation and practices follow Federal laws, rules, and regulations. 

• Documents and organizes required evidence, data, and other information to support 

violations noted during inspections, investigations, sample collections, field and label 

examinations, or entry filer audits. 

• Developmental assignments include assisting higher level employees in meetings and 

conference calls with importers, entry filers, consignees, and partner government 

agencies; assisting in team reviews by gathering scientific and technical comments 

from team members, assisting with the preparation of letters and correspondence 

relevant to the review; and contributing to status reports for submissions and 

investigations under review. 

• Incumbent interacts with and advises various levels of officials representing the 

establishments subject to regulatory review. The incumbent initiates contact with 

industry officials to obtain basic incomplete or missing information on regulatory and 

scientific documents and to discuss the status of investigations. Prepares final reports, 

affidavits, and other written documentation that support investigative findings and 

recommendations. 

• Testifies as an expert witness in administrative hearings and judicial proceedings.

Supervisory Responsibilities: This is a nonsupervisory role.

Conditions of Employment

• U.S. Citizenship requirement or proof of being a U.S. National must be met by closing date.

• Employment is subject to the successful completion of a background investigation, 

verification of qualifications, completion of onboarding forms, submission of required 

documents, and any other job-related requirement before or after appointment.

• Applicants must meet all qualification requirements by the closing date of this 

announcement.

• 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.

• One-year probationary period may be required. 

• Financial Disclosure may be required.

• Ethics Clearance may be required. 

• Background Investigation/Security Clearance is required. 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 later.
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Qualifications

To be placed into a Title 21 position, candidates must meet the following criteria:

1. Scientific, Technical, and Professional Fields

2. Qualified and Outstanding Candidates

a. Outstanding candidates can be defined by existing outstanding work experience, 

outstanding performance rating, or both.

b. Qualified applies to all candidates for Title 21 appointments. 

To qualify for this Title 21 Cures position, the candidate(s) must meet the following required

qualifications. Please note: Additional education and experience listed that is not indicated as 

required is preferable and desired. Candidates who do not meet the “desired” criteria will not be 

excluded from consideration for this position. 

Education Requirement: The education must have been obtained at a college, university, or an 

accrediting body recognized by the Secretary, U.S. Department of Education at the time the 

degree was obtained. 

Education/Experience Requirements: Candidate must meet the following: 

Education: A bachelor’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: Comparable 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. To qualify for Band A with no degree, you 

must have at least 4 years of comparable experience. To qualify for Band B with no 

degree, you must have at least 5 years of comparable experience.

Additional Requirements of this Position: 

• 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. 

• Candidates for this position must complete a statement regarding their physical ability 

and may be required to undergo physical examination because the position requires: 

The need to work long and unscheduled hours; Exposure to all kinds and extremes of 

weather and noise; The need to lift heavy objects up to 50 pounds, walk, bend, stand, 
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stoop, kneel, and climb; The need to meet the vision, hearing, and olfactory 

requirements necessary to perform the work of this position. 

• Position may include shift work and/or weekend work. 

• Travel approximately 25 percent of the time which may require Investigator to be away 

from the duty station for up to two to three weeks at a time.

Desired Experience: 

BAND A: Our ideal candidate will have:

• Knowledge and skill in applying critical thinking as it pertains to a wide range of complex 

professional theories, concepts, principles, standards, and methods to determine, 

execute, and explain actions that modify standard practices, equipment, devices, 

processes, and well-known techniques and resolve a wide variety of complications and 

constraints contained in traditional projects. 

• Skill to adapt precedents and existing strategies which allow occupational projects to 

meet unusual needs or demands and serves as a principal contributor for the assigned 

specialty areas on team-based projects. 

• Knowledge of and skill in selecting, adapting, and applying investigative methods and 

negotiating techniques to conduct complete and professional inspections and 

investigations, persuade reluctant persons and officials to provide information or access 

to information, and persuade industry representatives to agree to terms needed to 

achieve compliance. 

• Skill in planning and carrying out assignments, resolving most conflicts that arise, 

coordinating the work with others as necessary, and interpreting policy on own initiative 

in terms of established objectives. In some assignments, the employee also determines 

the approach to be taken and the methodology to be used. The employee keeps the 

supervisor informed of progress and potentially controversial matters. 

• Ability to apply judgment in interpreting and adapting guidelines, such as agency 

policies, regulations, precedents, and work directions for application to specific cases or 

problems. The employee analyzes results and recommends changes. 

BAND B: In addition to the skills/experience listed for Band B, the ideal candidate for Band B 

will also have the following skills and experience:

• Ability to coordinate a team project by providing technical oversight and direction for a 

variety of principal team members representing related professional disciplines, and 

evaluates and presents plans, designs, reports, and correspondence concerning projects 

and product issues.

• Skill in making decisions to assess unusual circumstances, variations in approach, and 

incomplete or conflicting data.

• Skill in analyzing and evaluating complex data samples and documented information 

gathered during inspections and investigations and utilizes novel approaches as needed 

to ensure compliance with federal laws, rules, and regulations.

• Ability to prepare final Establishment Inspection Report (EIR), investigations memoranda 
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and proposed or final endorsements for inspections and investigations.

• Ability to evaluate and make recommendations on the state of compliance of a 

firm/individual involved in the importation of FDA regulated products, or those who file 

entries on behalf of others. 

Education Transcripts

SUBMITTING YOUR TRANSCRIPTS: Positions which are scientific or technical in nature often 

have very specific educational requirements. A transcript is required to verify educational 

achievement. 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 FDA 

employee, you are not exempt from transcript requirements.

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 more information about this requirement, please visit the U.S. Department of 

Education website for Foreign Education Evaluation. 

Security Clearance Requirements

Background Investigation/Security Clearance Requirements: If not previously completed, a

background security investigation will be required for all appointees. Appointment will be

subject to the applicant’s successful completion of a background security investigation and

favorable adjudication. Failure to successfully meet these requirements may be grounds for

appropriate personnel action. In addition, if hired, a background security investigation or

supplemental investigation may be required later. 

Ethics Clearance Requirements

This position may require financial disclosure reporting and will be subject to FDA's prohibited 

financial interest regulation. If you are hired, you may be required to divest of certain financial 

interests. You are advised to seek additional information on this requirement from the hiring 

official before accepting any job offers. For more information, please visit the FDA Ethics web 

page: https://www.fda.gov/about-fda/jobs-and-training-fda/ethics. 

Equal Employment Opportunity 

The United States Government does not discriminate in employment based on race, color, 

religion, sex (including pregnancy and gender identity), national origin, political affiliation, 

sexual orientation, marital status, disability, genetic information, age, membership in an 

employee organization, retaliation, parental status, military service, or other non-merit factor.

Equal Employment Opportunity (EEO) for federal employees & job applicants
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Reasonable Accommodation

Federal agencies must provide reasonable accommodation to applicants with disabilities where 

appropriate. Applicants requiring reasonable accommodation for any part of the application 

process should follow the instructions in the job opportunity announcement. For any part of 

the remaining hiring process, applicants should contact the hiring agency directly. 

Determinations on requests for reasonable accommodation will be made on a case-by-case 

basis. A reasonable accommodation is any change to a job, the work environment, or the way 

things are usually done that enables an individual with a disability to apply for a job, perform 

job duties or receive equal access to job benefits. Under the Rehabilitation Act of 1973, federal 

agencies must provide reasonable accommodation when: An applicant with a disability needs 

accommodation to have an equal opportunity to apply for a job. An employee with a disability 

needs accommodation to perform the essential job duties or to gain access to the workplace.

An employee with a disability needs accommodation to receive equal access to benefits, such 

as details, training, and office-sponsored events. You can request reasonable accommodation 

at any time during the application or hiring process or while on the job. Requests are 

considered on a case-by-case basis. Learn more about disability employment and reasonable 

accommodations or how to contact an agency.

E-Verify

The Food and Drug Administration participates in the USCIS Electronic Employment Eligibility 

Verification Program (E-Verify). E-Verify helps employers determine employment eligibility of 

new hires and the validity of their Social Security numbers.

How to Apply

Applications will be accepted by all qualified applicants. Applicants must submit a letter of 

interest addressing experience in the major duties and responsibilities of the position, a 

detailed current resume, SF-50 (redacted for birth year and SSN) (for federal employees only) 

and college transcript(s) (with foreign credentials evaluation if applicable) to ORA Investigator 

Hiring at: ORAInvestigatorHiring@fda.hhs.gov. Applications will be accepted through April 10, 

2024. Applicants must reference 8-Inv II-OIO-name of preferred location(s) in the email subject 

line. 

Announcement Contact

For questions regarding this Title 21 position, please contact 

ORAInvestigatorHiring@fda.hhs.gov. 

The Department of Health and Human Services is an equal opportunity employer with a smokefree environment. 

FDA is an equal opportunity employer.