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:  This vacancy is open to current permanent (career/career-conditional appointments) employees of the Food and Drug Administration (FDA) ONLY.  Current FDA employees serving under a Schedule-A OR VRA appointment are eligible for consideration. Title 42 employees not eligible for reinstatement will not be considered. 

YOU MUST SUBMIT YOUR SF-50 (Notification of Personnel Action)

Current FDA 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 located in Montgomery County, 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 from this announcement.

Duties

The incumbent of this position serves as a regulations and regulatory policy analyst in the Office of Regulatory Affairs (ORA).   The incumbent assumes primary responsibility for ensuring that regulations and policies developed in the assigned areas are consistent with statutory requirements and existing policy, their need is justified, and that adequate scientific and medical reviews have been completed.

At the full performance level, the incumbent performs duties that include resolving a broad range of issues concerning the application of any of FDA's enabling legislation, pertinent regulations, and/or general legislation affecting the operation of the Federal government.   Assignments involve researching regulatory issues and revising existing or creating new policies and regulations.   Major duties include:

      Develops policies and programs involving complex and high priority matters affecting the all program areas within regulation of the Office’s program responsibility.   Drafts or critically reviews documents embodying policy and program proposals and decisions on these products.

·     Serves as a regulatory expert in matters related to his/her area of responsibility and is frequently called on to advise others, both internal and external to FDA, concerning FDA statutes, regulation, and policy. 

     Drafts or reviews proposals for new regulations and policy statements involving his or her area of regulatory expertise.   These regulations and policy statements often result from the need to implement new legislation or from new interpretations of existing legislation.

      Reviews, summarizes, and drafts responses to all public comments received on proposed regulations; recommends adoption or rejection of counter-proposals contained in comments and objections; drafts final regulations.

      Reviews petitions raising issues that affect a segment of the regulated industry as well as those that pertain to the marketing status of individual products.   Develops a course of action and drafts responses to such petitions.

      Prepares replies to correspondence from the regulated community and other interested persons on issues that affect one or more portions of the regulated industry are industry-wide in scope or have broad health implications and that concern precedent setting interpretations of FDA policy.

·     May make presentations at conferences and professional meetings before the regulated industry, clinical investigators, and the medical/scientific community on the applicable regulations and policies.

Duties at the trainee levels will be selected by the supervisor and will be developmental in nature.