Job Overview

Summary

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.  It 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.

 

Who May Apply:  This vacancy is only open to current Food and Drug Administration (FDA) employees with competitive status.  Competitive status refers to employees who are serving on a career or career conditional appointment.

 

PHS Commissioned Corps Officers interested in performing the duties of this position within the Commissioned Corps may apply online to this announcement.  Candidates will be referred as (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment.

 

YOU MUST SUBMIT YOUR SF-50 (AND DD-214 IF APPLICABLE). 

 

This position is located in the Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Southeast Region, Atlanta District Office, Investigations Branch, Atlanta, GA.

 

This announcement may be used to fill multiple positions in multiple locations.

Duties

Major Duties:

The incumbent plans, conducts and directs highly technical, complex and multi-faceted inspections and in-depth investigations in the area of medical devices and diagnostic programs and is highly skilled in interview techniques as well as criminal investigation techniques. Routinely makes recommendations to regional and district management officials on whether or not firms/individuals involved in the production, control and testing of medical devices and diagnostic products are in compliance with Current Good Manufacturing Practices (CGMP).  Reviews reports of inspections and investigations for violations and determines the sufficiency of the evidence. Provides extensive advisory, liaison and consultative services for medical device programs to regulated industries, state and Federal agencies and agency management.  Serves on task forces and study groups charged with considering problems or directions in the area of medical devices; serves as expert witness in court cases dealing with regulated products; evaluates and makes recommendations on necessary regulatory action required for complaints. Serves as principal advisor or team leader in a field of regulatory and compliance expertise and is responsible for planning, coordinating and evaluating the programs and activities for a professional regulatory field