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.

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 and enforcement.

Who May Apply:  Federal employees with career or career-conditional appointments in the competitive service; former Federal employees with reinstatement eligibility based on previous career or career-conditional appointments; displaced Federal employees requesting special priority selection consideration under the Career Transition Assistance Plan (CTAP) and the Interagency Career Transition Assistance Program (ICTAP); veterans who are preference eligibles or who have been separated under honorable conditions after 3 years or more of continuous active service; individuals eligible for VRA appointments; Military Spouses; PHS Commissioned Corps Officers; and individuals with disabilities.

YOU MUST SUBMIT YOUR SF-50 (Notification of Personnel Action) and/or Form DD-214 OR YOUR APPLICATION WILL BE CONSIDERED INCOMPLETE.

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 the selecting official as Commissioned Corps (CC) personnel and not as candidates for conversion to a permanent career or career-conditional appointment. 

LOCATION: This position is located in the Food and Drug Administration, Office of Global Regulatory Operations and Policy, Office of Regulatory Affairs, Office of Policy and Risk Management.  Duty station will be in either Rockville or Silver Spring, Maryland.

The salary listed in the vacancy announcement includes the geographical locality pay. 

TYPE OF POSITION: This position is being filled on a full-time, permanent basis.

PROMOTION POTENTIAL:  This is a career-ladder position; GS-13 is the full performance level.

Additional selections may be made within the same geographical area within FDA-wide.

Duties

The purpose of this position is to enforce the laws and regulations protecting consumers from foods, drugs, cosmetics, fabrics, toys, and household products and equipment that are impure, unwholesome, ineffective, improperly or deceptively labeled or packaged, or in some other way dangerous, or defective. The position can also involve the development of policy, regulations, and process that are implemented in the Food and Drug Administration (FDA) Field Offices (FOs). Represent FDA before administrative hearings or in court. At the full performance level, major duties include:

  • Answers inquiries from other Federal, State or local agencies, foreign missions, Industry, and importers regarding interpretations of Agency-enforced laws and regulations, case status, and enforcement policies.
  • Researches and prepares final background and decision papers for the signature of the Director. Prepares memoranda, briefings, and other background material concerning substantive issues, findings, conclusions and proposed solutions to keep the Director and appropriate staff involved at key decision points.
  • Serves on task forces and study groups charged with considering problems or directions in the area of expertise. Consults with staff members at all levels of the organization to achieve consensus on issues and resolve any disagreements on standards. Represents the agency on inter-agency review committees charged with reviewing Federal policies and making recommendations for consistency across agency lines.
  • Provides authoritative interpretations of applicable laws, regulations, and programs, advises management on a wide range of regulatory problems related to the industries regulated by FDA and recommends appropriate legal actions.
  • Reviews special and unusual problems submitted by various FDA areas and provides authoritative guidance to the resolve the issues causing the problems. Such issues frequently deal with interpretations of law, policy and procedures.
  • Conducts research into legal precedents and legislative history of the Acts enforced by FDA. Prepares position papers for top FDA managers based on such research. Drafts responses to correspondence from within and outside the agency concerning FDA regulated products.