Investigator I, Band Y (GS-09 Equivalent)

Summary

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. This position is being recruited based on the Title 21 Pay Table 1, Band Y (GS-9 equivalent).

This job is open to

• The public
• U.S. Citizens, Nationals or those who owe allegiance to the U.S.

Clarification from the agency

You must be a U.S. Citizen or U.S. National. Foreign nationals or legal permanent residents are not eligible for consideration. This is a 21st Century Cures Act authority announcement. Traditional federal rules regarding rating, ranking, and veterans' preference do not apply.

Duties

Office of Medical Device and Radiological Health Inspectorate Investigator I assignments involve a combination of scientific and regulatory responsibilities which usually call for inspections or investigative approaches to be applied to a wide variety of regulatory functions or scientific evaluations and include sample collections, medical device establishment inspections, and investigations. Incumbent performs analyses and evaluation on data samples and documented information gathered during medical device inspections and investigations to ensure that documentation and practices are in compliance with Federal laws, rules, and regulations.

Inspections and Investigations

• Plans and conducts routine regulatory medical device inspections and limited investigations of various industry establishments; such as manufacturers, re-packers, own label distributors, and importers.
• Independently carries out routine investigations, inspections, entry review, filer audits and sampling.
• Upon completion of assignment, prepares concise factual reports reflecting significant observations. Incumbent surveys and follows up with non-compliant industry establishments where violations are clear- cut and seeks voluntary compliance. In situations where compliance is not offered it is enforced through other methods, including administrative action, informational agency meetings and legal court actions.
• Performs other duties as assigned.
• Analysis and ReportingConducts analyses and evaluation on data samples and documented information gathered during medical device inspections, RRAs, and investigations to ensure that documentation and practices comply 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.
• 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.
• Developmental assignments include assisting higher level employees in the review and evaluation of inspection reports of products or establishments submitted by the field for regulatory action consideration. Additional Developmental assignments include providing support (i.e., documenting conversations and noting circumstances) to higher level employees as they interact with industry officials on regulatory issues.
• Prepares final reports, memoranda, position papers and other written documentation that support investigative findings and recommendations. Reports are developed and, in most instances, accepted with little review of format or content.
• May be called to testify as an expert witness in administrative hearings and judicial proceedings.

Supervisory Responsibilities: This is a non-supervisory role.