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.

 

This position is located in the Department of Health and Human Services (DHHS), Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA), Central Region-Baltimore District with locations in either Falls Church, VA; Richmond, VA or Baltimore, MD.

 

The FDA's Office of Regulatory Affairs is the lead office for all FDA Field activities as well as providing FDA leadership on imports, inspections, and enforcement policy.  ORA supports FDA Product Centers by inspecting regulated products and manufacturers, conducting sample analysis on regulated products, and reviewing imported products offered for entry into the United States.  ORA also develops FDA-wide policy on compliance.

 

Who May Apply:  Open to all United States Citizens.

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

 

Announcement amended to add Baltimore, MD location and the closing date has been extended until 05/21/13.

 

 

Duties

The incumbent will conduct inspections and investigations 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.  Inspections cover all the types of products and problems within the area of assigned responsibility.  Investigates and evaluates the adequacy of complex manufacturing practices to determine compliance with GMP regulations.  Investigations involve complaints of injury or death attributable to products regulated by the FDA.  Investigations of injuries require special coordination and a high degree of insight and knowledge.  Plans and decides how the investigation should proceed, when the investigation is complete, and what reporting is required.  Analyzes results, decides when an investigation is complete or what additional work may be required.