The incumbent serves as the Director, Office of Medical Products and Tobacco Operations in the Office of Operations (OO) for the Office of Regulatory Affairs (ORA) in the Office of Global Regulatory Operations and Policy (OGROP). As the Director, the incumbent serves as the Senior Medical Products and Tobacco Operations Officer, who will be a key member of the senior management team of the Associate Commissioner for Regulatory Affairs (ACRA) and Assistant Commissioner for Operations (ACO), which has responsibilities for decision making processes and leads discussions and decision-making concerning ORA plans, programs, and activities, both during strategic planning sessions and in the actual determination, allocation, and administration of ORA program segment(s), functions, and activities.
The incumbent provides expert advice and counsel concerning approaches and options that are sound and feasible in relation to ORA's regulatory goals and objectives. As the Senior Medical Products and Tobacco Operations Officer, the incumbent serves as the principal advisor to the ACO and ACRA and is recognized as the person who can speak authoritatively for the ACO and ACRA on matters pertaining to the OMPTO programs.
The incumbent represents the Agency, the ACRA and/or the ACO in meetings, conferences, and committees involving policy and other matters pertinent to the Office of Medical Products and Tobacco Operations programs; provides input from the ACRA concerning critical and significant issues and regulatory activities to resolve regulatory questions and issues relating to medical and tobacco products; and coordinates with FDA Centers, ORA Headquarters (HQ) components, ORA Regional and District Offices, other Federal agencies, international and state and local governments concerning the interpretation of regulatory requirements, impacts, and other issues.
The incumbent represents the ACRA and/or the ACO in dealing and negotiating with representatives of Congress; HHS Operating Divisions, other federal agencies; state, local, and, at times, foreign governments; the regulated industry; professional and industry organizations; and public interest groups and provides authoritative counsel and guidance concerning critical and significant regulatory questions and issues related to medical and tobacco products.
Oversees the implementation of new laws and regulations, which impact the mission of ORA and OMPTO. This includes responsibility for the initiation and implementation of new policies, systems, and procedures.
The incumbent is responsible for analysis of the impact of proposed changes to Agency laws and regulations, policies, and procedures, which affect the functions, program segment(s), and activities of ORA's HQ and field offices that are involved with FDA's/ORA's nationwide regulatory and compliance operations as they relate to medical products (e.g., drugs, biologics and devices) and tobacco program operations. Identifies changes and additions to the functions, program segment(s), and activities of ORA necessary to implement new legislation or regulations, and develops various scenarios for dealing with expansion or contraction of ORA functions, program segment(s), and activities in relation to investigational and regulatory efforts in the medical products and tobacco operations programs.
The incumbent oversees, monitors and evaluates and provides guidance on the effectiveness of Regional and District Office investigational, regulatory and compliance activities related to food and feed program operations. Provides guidance on matters which cannot be resolved at the local level and coordinates efforts among the various offices.