Job Overview


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 Food and Drug Administration (FDA) is a Federal scientific law enforcement agency with the legislated responsibility for ensuring that drugs, biological products and medical devices are safe and effective, that food and drugs are adequately packaged and informatively labeled and that radiation emitting devices are safe, and to prevent and reduce tobacco use. The work of the FDA is carried out by thousands of personnel stationed throughout the United States and abroad. The staff includes physicians, scientists, engineers and a variety of other multidisciplinary professional, technical and support personnel. FDA’s programs are national in scope and international in effect, and its activities directly affect and heavily impact upon multi-billion dollar industries, in addition to protecting the public health of hundreds of millions of American consumers.

This is a Senior Level (SL) executive position is located in the Food and Drug Administration, Office of Global Regulatory Operations and Policy, Office of Regulatory Affairs, Office of Medical Products and Tobacco Operations in Silver Spring, MD.

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; and individuals with disabilities. YOU MUST SUBMIT YOUR SF-50 AND/OR DD FORM 214.

This position is located on the staff of the Assistant Commissioner for Operations in the Office of Regulatory Affairs (ORA). The ORA plans and directs the management and administration of personnel and facilities to ensure the federal laws and regulations regarding FDA regulated products are enforced. ORA directs nationwide field operations that are performed by several thousand scientific, professional, regulatory and consumer safety personnel geographically dispersed throughout the nation and abroad; and manages state-of-the-art scientific laboratories strategically located throughout the U.S. and Puerto Rico.

The Director, Office of Medical Products and Tobacco Operations, serves as the principal advisor to the Assistant Commissioner for Operations (ACO).  In addition, the incumbent serves as the supervisor of Division of Medical Products and Tobacco Program Operations and the Division of Medical Products and Tobacco Inspections.




As the Director, the incumbent performs substantive work and participates with the ACO by providing leadership and strategic advise in the development, implementation and evaluation of regulations and policies as they relate to ORA’s broad national and international programs and activities to ensure the safety, quality, efficacy, and labeling, in their specialized functional areas, such as FDA regulated human drugs, biologics, animal drugs, medical devices and tobacco products. 

a.    Represents and makes decisions on behalf of the ACO relative to medical products and tobacco programs investigatory operations, including emergency response activities.

b.    Represents and speaks for the ACRA in discussions, meetings, conferences, and consultations with top-level departmental and agency officials, national/international industry representatives, academic organizations and groups, foreign officials, members of Congress and/or their representatives, personnel from other executive departments and independent Federal agencies, State and local governmental counterparts and others to secure and provide information concerning critical and significant issues, actions and regulatory activities related to ORA programs and to resolve complex regulatory questions and issues that arise.

c.    Participates with the ACRA, senior officials and others in preparing for and/or testifying before Congress on agency regulatory programs and activities. As the focal point of information on ORA regulatory matters, provides authoritative advice, guidance, assistance, interpretations, and recommendations to key agency officials, programs directors, professional personnel, departmental representatives, intra/inter-governmental counterparts and others on problems related to Center regulated products. Furnishes expert advice and comments on matters related to existing programs and regulations and proposes new programs and regulations.

d.    Provides leadership and direction on the application of risk management and program evaluation techniques to regulatory compliance activities so that limited resources can provide the most public health promotion/protection at the least cost to the public. Works closely with Agency risk management and program evaluation experts, including those in ORA, the Centers and the Commissioner’s Office, to identify opportunities for enhanced coordination and better approaches to identifying, prioritizing, and managing risk through field compliance programs, and other approaches including 32 enhanced collaboration within FDA and counterpart governmental agencies, domestically and abroad, and other interested stakeholders.