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 open to current Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA) employees with competitive status only.  Competitive status refers to employees who are serving on a career or career conditional appointment.

 

FDA/ORA 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 to (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, Office of Regulatory Affairs, Central Region, Philadelphia District Office, located in Philadelphia, PA.

 

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

Duties

Major Duties:
This position serves as both a Compliance officer and a Recall Coordinator.  Duties and responsibilities include:

Compliance Officer (at least 25%):

  • Reviews and evaluates evidence and findings indicating lack of compliance with enforced laws and regulations.
  • Perform analyses and evaluation on data samples and information gathered during inspections and investigations.
  • Analyzes studies results, determine the completion of investigations and suggest additional work if necessary.  Determines and recommends the most suitable for of action including legal actions.
  • Prepares and conduct hearings with noncompliant establishments.
  • Seeks court enforced compliance through legal action against violators in a court of law.
  • Maintains liaison with U.S. Custom officials facilitating import inspections for compliance with FDA regulations.

Recall Coordinator:

  • Resolves the most difficult, controversial and complex recalls.
  • Develop recall strategy, recall notification letters and draft press release to assure accuracy of the information reported.
  • Obtains information about potential and ongoing recall situations from industry, FDA District Offices, Federal and state agencies.
  • Prepares recall alerts and recall recommendations to assess the health hazard of a recall product and provide a course of action.
  • Primary contact for the State Department of Health, and other federal agencies in the area of recalls.
  • Plans. organizes and implement training and technical programs to promote compliance with agencies policies and regulations.
  • May be given assignments involving investigations or inspections of firms.