Title 21: 21st Century Cures Act Positions
The 21st Century Cures Act was enacted on December 13, 2016 and Section 3072 of the Act grants the Commissioner of Food and Drugs the authority to appoint and set the annual rate of pay for outstanding and qualified candidates to scientific, technical, or professional positions that support the development, review, and regulation of medical products.
The positions listed below are being filled under an excepted hiring authority, Title 21, Section 3072 of the 21st Century Cures Act. The candidate selected for these positions will serve under a career or career-conditional appointment and be paid under the provisions of the authority. Additional information on 21st Century Cures Act can be found here.
Title 21 Open Vacancies
OHT7 Deputy Office Director (Patient Safety and Product Quality)
The Center for Devices and Radiological Health (CDRH), Office of Product Evaluation and Quality (OPEQ), Office of In Vitro Diagnostics and Radiological Health (OHT7) is recruiting for a Deputy Office Director (Patient Safety and Product Quality) to lead, manage, and set strategy for OHT7 staff and serve as the technical authority and principal advisor to the OHT7 and OPEQ Directors on scientific and technical topics within OHT7.
OHT6 Office Deputy Director (Supervisory Interdisciplinary Scientist)
The Center for Devices and Radiological Health (CDRH), Office of Product Evaluation and Quality (OPEQ), Office of Health Technology-6 (OHT6) is recruiting for an Office Deputy Director (Supervisory Interdisciplinary Scientist) serves as the technical authority and principal advisor to the OHT6 and OPEQ Directors on scientific and technical topics within OHT6.
Office Director
The Center for Drug Evaluation and Research (CDER) , Office of Pharmaceutical Quality (OPQ), Office of Quality Surveillance (OQS) is recruiting for an Office Director to provide technical expertise and executive leadership with oversight and responsibilities related to quality surveillance of pharmaceutical products and facilities.
Associate Director of Regulatory Affairs
The Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ), Office of Pharmaceutical Manufacturing Assessment (OPMA) is recruiting for an Associate Director of Regulatory Affairs to serve as the principle advisor to the Office Director or Deputy Office Director and provides staff leadership and direction by performing substantive activities related to the planning, development, administration, execution, and coordination of activities associated with the work within the offices scope of responsibility.
Assistant Director (Supervisory Interdisciplinary Scientist)
The Center for Devices and Radiological Health (CDRH), Office of Product Evaluation and Quality (OPEQ), Office of Health Technology 7 (OHT7), Division of Chemistry and Toxicology Devices (DCTD) is recruiting for an Assistant Director (Supervisory Interdisciplinary Scientist) to serve as the Assistant Director of the Diabetes Diagnostic Devices Branch within DCTD.
Epidemiologist
The Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE) is recruiting for an Epidemiologist to provide regulatory expertise in the use of various data sources and methodologies to assess and inform drug safety and the observational aspects of drug efficacy/effectiveness evaluations.
Associate Director for Science
The Center for Biologics Evaluation and Research , Office of the Center Director is recruiting for an Associate Director for Science to serve as a key member of CBER’s Senior Leadership Team and is responsible for high level strategy, promotion and coordination of all scientific research activities conducted by the Center and for assuring their high quality, focus and scientific, and public health outcomes.
Assistant Director (Supervisory Interdisciplinary Scientist)
The Center for Devices and Radiological Health (CDRH), Office of Product Evaluation and Quality (OPEQ), Office of Health Technology 7 (OHT7), Division of Chemistry and Toxicology Devices (DCTD) is recruiting for an Assistant Director (Supervisory Interdisciplinary Scientist) to serve as the Assistant Director of the Diabetes Diagnostic Devices Branch within DCTD.
Supervisory Consumer Safety Officer (Advanced Medical Product Manufacturing)
The Office of Regulatory Affairs (ORA), Office of Medical Products and Tobacco Operations (OMPTO) is recruiting for a Supervisory Consumer Safety Officer (Advanced Medical Product Manufacturing) to serve as the ORA authority with the advanced medical product manufacturing industry and FDA authority on medical product programs.
OSEL/DBP Assistant Director (Supervisory Interdisciplinary Scientist)
The Center for Devices and Radiological Health (CDRH), Office of Science and Engineering Laboratories (OSEL), Division of Biomedical Physics (DBP) is recruiting for an OSEL/DBP Assistant Director (Supervisory Interdisciplinary Scientist) to provide technical and scientific consultation to division, office, Center and other high-level officials on program status, plans, trends and significant problems.
Regulatory Counsel
The Center for Drug Evaluation and Research (CDER), Office of Drug Security, Integrity, and Response (ODSIR) is recruiting for a Regulatory Counsel to serve as an expert in the statutes, regulations, policies, procedures, and implications relevant to the issuance of FDA regulations, conduct sophisticated analyses of complex regulatory and policy issues for the CDER imports and recalls program areas and leads policy development activities.
Diversity Program Manager
The Center for Veterinary Medicine (CVM), Office of the Director (OD) is recruiting for a Diversity Program Manager to report to the Director, CVM providing expert advice and consultation on Diversity, Equity, and Inclusion (DEI).
Division Director
The Center for Devices and Radiological Health (CDRH), Office of Product Evaluation and Quality (OPEQ), Office of Clinical Evidence and Analysis (OCEA), Division of Clinical Evidence and Analysis 2-Biostatistics (DCEA2) is recruiting for a Division Director to provide executive leadership and exercise biostatistics judgment and activities in the area of both therapeutic and diagnostic devices.
Supervisory Data Officer
The Center for Devices and Radiological Health (CDRH), Office of Strategic Partnerships and Technology Innovation (OST), Division of Technology and Data Services (TDS), Data Services Team (DST) is recruiting for a Supervisory Data Officer to lead the Center’s data modernization initiative. In directing this initiative, you will guide all enterprise-wide data architecture and technology effort, spearhead the Center’s data modernization program, and develop, define, and direct all data governance strategies.
Regulatory Counsel
The Center for Veterinary Medicine (CVM), Office of the Director (OD) is recruiting for a Regulatory Counsel to conduct legal analyses of CVM and Agency records to determine whether documents can be released in litigation or in response to third-party subpoenas.
Consumer Safety Officer
The Center for Drug Evaluation and Research (CDER), Office of Compliance (OC) , Office of Manufacturing Quality (OMQ) is recruiting for a Consumer Safety Officer to serve as a scientific advisor for case development, compliance strategies, and regulatory actions, including enforcement, relating to medical drug products, and performs substantive work with a multiplicity of unprecedented and complex scientific topics.
Information Technology (IT) Specialist (2 Vacancies)
The Center for Veterinary Medicine (CVM), Office of Management (OM), Business Informatics Staff (BIS) is recruiting for Information Technology (IT) Specialists to serve as a technical authority on the database systems used to support the Center’s business processes and procedures.
Director, India Office
The Office of the Commissioner (OC), Office of Policy, Legislation and International Affair (OPLIA), Office of Global Policy and Strategy (OGPS), Office of Global Operations (OGO) is recruiting for a Director in the India Office to serve as the in-country agency focal point for international programs and interactions with foreign counterpart regulatory agencies, international organizations, foreign embassies and officials, the Department of Health and Human Services, and other USG components when country-specific issues are involved.
Regulatory Counsel
The Center for Drug Evaluation and Research (CDER), Office of Generic Drugs (OGD), Office of Generic Drug Policy (OGDP), Division of Legal and Regulatory Support (DLRS) is recruiting for a Regulatory Counsel to assume primary responsibility for ensuring that regulations and policies developed in the assigned area are consistent with statutory requirements and existing policy.