***HIRING IN MULTPLE LOCATIONS***

Location(s): Multiple vacancies in the following locations: Nogales, AZ; San Diego, CA; Miami, FL; Miami Lakes, FL; Eastport, ID; Itasca, IL; Covington, LA; Winchester, MA; Baltimore, MD; Owings Mills, MD; Houlton, ME; Detroit, MI; Maplewood, MO; Sweetgrass, MT; Pembina, ND; Newark, NJ; Alexandria Bay, NY; Buffalo, NY; Champlain, NY; Jamaica, NY; Ogdensburg, NY; Brunswick, OH; Philadelphia, PA; Memphis, TN; San Juan, PR; Houston, TX; Laredo, TX; Pharr, TX; Falls Church, VA; Portsmouth, VA; Highgate Springs, VT; Blaine, WA; Seattle, WA

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 FDA regulated 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.

Duties/Responsibilities

The Investigator II / Senior Investigator I 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.

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.

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, SF-50 (redacted for birth year and SSN – for federal employees only) 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 July 15, 2024, or until all positions have been filled.

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

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 smoke-free environment.

FDA is an equal opportunity employer.