Investigator II/Senior Investigator I

***HIRING IN MULTIPLE LOCATIONS***

Please reference the official job announcement for location details: https://www.fda.gov/media/178584/download?attachment

IN: Indianapolis

NJ: Parsippany

PA: Philadelphia, Pittsburgh

MD: Owings Mills

OH: Brunswick

MA: Stoneham

MN: Minneapolis (Milwaukee)

NC: Raleigh

GA: Atlanta

TN: Memphis

IL: Chicago

CA: South San Francisco,

Alameda, San Jose, Irvine

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.

Additional information on 21st Century Cures Act can be found here: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act

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/fda-organization/office-regulatoryaffairs 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 Medical Products and Tobacco Operations (OMPTO) oversees four program directors in the coordination, interpretation, and evaluation of the Agency’s overall field inspections and compliance efforts in the areas of medical products and tobacco. OMPTO is led by an Assistant Commissioner for Medical Products and Tobacco Operations (ACMPTO) who reports directly to the Associate Commissioner for Regulatory Affairs.

The Office of Medical Device and Radiological Health Operations (OMDRHO), a program within the

Office of Medical Products and Tobacco Operations in the Office of Regulatory Affairs (ORA), provides advice and counsel to ORA and FDA leaders regarding medical devices and radiological health program operations, including emergency response activities. OMDRHO collaborates with the agency’s Center for Device and Radiological Health (CDRH) on all FDA-regulated medical devices and radiation-emitting products.

Duties/Responsibilities

The Investigator/Senior Investigator has demonstrated and is recognized for a high level of competence in the full range of establishments regulated within the OMDRHO program such as: inspections and investigation of manufacturers, specification developers, contract manufacturers, sterilizers, initial importers, and distributors.

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 the most difficult and complex sample collections, establishment inspections, unusual or novel special investigations and conducting objective surveys and emergency activities within the assigned area of responsibility.

Inspection and Investigation

• Independently plans and conducts regulatory inspections and in-depth investigations of various industry establishments, such as manufacturers, specification developers, contract manufacturers, sterilizers, initial importers, and distributers. Assignments are frequently complicated by a variety of diverse products, highly specialized and sophisticated processes and equipment, products that are misbranded or adulterated or unapproved, complex quality control systems, or uncooperative establishment management. The Investigator conducts inspections and investigations (domestic and/international) of facilities where only limited guidance documents are available, proposed or new regulations must be used to evaluate the industry, or the inspection or investigation may result in considerable attention and review in the media, Congress, or other forces inside or outside the Agency.
• Incumbent performs various activities including domestic sample collections, establishment inspections, unusual or novel special investigations, remote regulatory assessments (RRAs), recall audit checks, and emergency activities of moderate difficulty within the incumbent's assigned area of responsibility.
• Incumbent interacts with and advises various levels of management officials representing the regulated industry, associations, state, local and foreign governments including those which may be contentious and require special skills to moderate conversations.
• 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.
• Assists the immediate supervisor or a team leader by planning inspections, investigations, sample collections, and related activities in the area of assigned responsibility, trains new personnel and providing training for personnel, trains State and local government personnel and when required, conducts international inspections.
• Performs investigations involving complaints of illness, injury, or death attributable to products regulated by the FDA.
• Judgment must be used to make field decisions on the nature and extent of investigations and inspections. Incumbent conducts re-inspections to follow up with non-compliant industry establishments on previously noted violations.

Analysis and Reporting

• Incumbent performs analyses and evaluation on potentially complex data samples and documented information gathered during inspections and investigations, utilizing novel approaches as needed to ensure compliance with Federal laws, rules, and regulations. Documents and organizes required evidence, data, and other information to support violations noted during inspections, RRAs, investigations and sample collections. Interacts with and advises various levels of officials representing the establishments subject to regulatory review. Initiates contact with industry officials and manufacturers to obtain basic, incomplete, or missing information on regulatory and scientific documents, to discuss the status of investigations, and to attend meetings and conference calls.
• Prepares final EIR, investigations memoranda, and proposed or final endorsements for inspections and investigations conducted. Reports are developed and well-written in accordance with quality elements.

Supervisory Responsibilities: This is not a supervisory role.

How to Apply

Applicants must submit (1) letter of interest that includes the state(s)/city(s) for which you are

interested; (2) a detailed current résumé; (3) transcripts (with foreign credentials evaluation if

applicable); (4) for federal employees only, redacted SF-50 (redact birth year and last for digits of SSN only).

Send the above documents to the ORA Executive Recruitment and Scientific Staffing Committee,

[email protected].

IMPORTANT: The application must show this job reference ID in the subject line: 8-OMDRHO-MD

Investigator-Location Reference Code(s). E.g., 8-Investigator-OMDRHO1, OMDRHO2

Applications will be accepted through July 22, 2024. Candidate resumes may be shared with hiring

official within the Office of Regulatory Affairs with a similar job vacancy. Candidates can opt out of this process by annotating resume with “do not share”.

Announcement Contact

For questions regarding this Title 21 position, please contact [email protected].

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

FDA is an equal opportunity employer.