The Food and Drug Administration is the regulatory, scientific, public health, and consumer protection agency responsible for ensuring that all human and animal drugs, and medical devices are safe and effective, that cosmetics, foods, food additives, drugs and medicated feeds for food producing animals, and radiation emitting devices are safe, and that all such products marketed in the United States are adequately, truthfully and informatively labeled and safely and properly stored, transported, manufactured packaged and regulated. FDA’s programs are national in scope and effect, and the agency’s activities have a direct and significant impact on multi-billion-dollar industries, in addition to protecting the health and safety of American Consumers. The work of the Agency is carried out by a staff of more than 18,000 scientists, physicians, regulatory and other personnel stationed throughout the United States.
The mission of the Office of Regulatory Affairs (ORA) is to protect consumers/patients and enhance public health by ensuring timely access to safe, quality FDA-regulated products. To view our ORA Vision, Mission, and Values please visit: https://www.fda.gov/about-fda/fda-organization/office-regulatory-affairs.
The Office of Regulatory Affairs (ORA) is at the forefront of building a public health safety net for today’s complex, global regulatory environment. ORA professionals work in a range of program areas and locations, with 227 offices and 12 laboratories throughout the United States. As the lead office for all FDA field activities, ORA serves as the agency’s direct connection with regulated industry through a) inspections of firms and plants producing FDA-regulated products, b) investigations of consumer complaints, emergencies and criminal activity, c) enforcement of FDA regulations, d) sample collection and analysis, and e) review of imported products.
The Office of Regulatory Science (ORS) provides strategic leadership, coordination, and expertise to the Associate Commissioner for Regulatory Affairs (ACRA), Deputy Associate Commissioner for Regulatory Affairs (DACRA) and other ORA senior leaders on scientific issues related to policy and regulations.
The Office of Human & Animal Food Laboratory Operations (OHAFLO) advises the ORS on scientific issues related to human and animal food laboratory operations and provides strategic leadership and support for high quality, collaborative, scientific activities that advance regulatory science and address important public health issues concerning the Food and Drug Administration (FDA) regulated products, including their evaluation, quality, safety, and effectiveness.
The Chemist (Advanced Analyst) serves as an analytical instrumentation specialist within the San Francisco Human and Animal Food Laboratory (SANLHAF) where they are recognized as the expert, technical authority, and resource person in this specialization. Examples of highly technical chemistry instrumentation include—but are not limited to: Inductively Coupled Plasma Mass Spectrometry (ICP-MS), or Liquid Chromatography with Tandem Mass Spectrometry (LC-MS/MS). Operates and maintains highly technical chemistry scientific equipment, same as or equivalent to the examples previously listed. Conducts studies and approved industry analytical procedures in various areas of agency concern to identify and quantify contaminants and adulterants in FDA-regulated products. May be required to troubleshoot the instrumentation such as hands-on maintenance and repair. Formulates and conducts research that evaluates new chemistry instrumentation and its applicability to the required analyses. Plans and performs the development of analytical methods in accordance with FDA needs and priorities, which requires a strong understanding of the ISO 17025 accreditation requirements as they apply to maintaining and verifying instrumentation performance. Performs verifications and validations of new chemistry methods.