Total 8 job vacancies by Food and Drug Administration

• This position(s) is located in the Food and Drug Administration (FDA), Center for Devices and Radiological Heath (CDRH), in Silver Spring, Maryland.
• Review scientific data submitted in support of a variety of medical device submissions to determine the safety and effectiveness.
• Review data in the field of general engineering, summarizes it and makes recommendation concerning the data, also provides leadership and guidance in general engineering to other supporting level scientists.
• Provide scientific information and consultation to industry, academic, and private laboratory scientists conducting research on the safety and effectiveness of materials used in the manufacture of medical device products or other scientific systems.

The selectee will serve as a Information Technology Specialist. Typical work assignments include:

• Assisting in the implementation, testing, and maintenance of IT systems and databases to ensure they meet user requirements and design specifications.
• Supporting data governance and management activities to ensure data quality, adherence to data standards, data accessibility, and compliance with regulatory requirements.
• Creating reports and data visualizations to assist staff in data analysis and decision-making processes.
• Assisting in gathering and documenting business requirements for IT solutions.
• Supporting IT project management activities in the development and maintenance of IT systems.

• Provide expert advice and counsel to Food and Drug Administration (FDA) senior officials on a broad range of administrative program management initiatives related to addressing Presidential, Department, or Agency priorities.
• Exercise supervisory and managerial authorities over the Office of Commissioner (OC) Information Technology liaisons (i.e.,CITL) which is responsible for all OO and OC Help Desk ticketing and answering IT questions and matters.
• Direct special studies and workgroups to evaluate operational and budgetary effectiveness for IT through strategic thinking, critical analysis, resources performance management, policy development, and customer-relations management.
• Using knowledge of the FDA budget process, specifically IT cost allocation model, and applying federal Capital Planning and Investment Control practices, work across OC to compile and maintain annual and strategic budgets for the OC.
• Use an orderly, logical, and efficient approach to diagnosing issues/problems to assess impact on organizational initiatives: identify and gather relevant information; assess short- and long- term impact of decisions.
• Provide authoritative guidance to Agency of Office review boards in connection to the efficiency of businesses processes as related to the Information Technology (IT) systems used for regulatory operations.

• Serve as an expert and stay current on Freedom of Information Act (FOIA) and work proactively with program offices to develop and implement strategies to avoid litigation.
• Serve as a recognized technical authority in planning and responding to FOIA requests for the Division of Headquarters Freedom of Information (DHFOI).
• Develop, control, manage, and coordinate the Division of Headquarters Freedom of Information (DHFOI) disclosure activities.
• Consult with senior staff members and other personnel to obtain their suggestions for regulations and policy development.
• Provide guidance and direction to personnel involved with handling responses to requests for information related to statutes, policies and/or regulations.

• Serve as the technical expert for the dissemination, collection, and review of confidential/public financial disclosure reports and outside activities and other related ethics matters for FDA employees and/or senior level officials.
• Supervise, lead, guide and direct the day to day activities for the team members ranging in grades GS-07 through GS-13.
• Responsible for applying equal opportunity principles in all individual, team, and work place activities.
• Interpret and apply laws, statutes, executive orders, regulations, Office of Government Ethics, and HHS guidance as it pertains to requests from employees including top FDA management for financial and conflict of interest advice and guidance.
• Prepare written guidance concerning sensitive and high-profile issues and advises management accordingly.
• Serve as advisor to the agency ethics staff on issues pertaining to the review and analysis of financial disclosure reports.
• Help ensure that filed reports required by public, confidential filers and non-filers are free of conflicts of interest in accordance with application of FDA supplemental regulations and Standards of Ethical Conduct for Employees of Executive Branch.

• Presents findings and evaluation of possible courses of action for resolving contractual issues; and draws conclusions based on relevant facts and expertise of acquisition program activities.
• Analyzes new and amended guidance from Office of Acquisitions or related regulation and develops policy/processes related to acquisitions activities.
• Consults with program officials and an office of acquisitions regarding technical aspects of the procurement processes.
• Provides program/acquisition advice and assistance, oral and written inquiries to the program office/management.
• Prepares relevant documents and packages to submit to an Office of Acquisitions and program office.
• Serves as acquisition technical liaison between program officials and an office of acquisitions by monitoring the Contractor's performance and delivery of the final products and/or services under the contract.
• Must have technical proficiency, expertise and compliance with the Federal Acquisition Regulations (FAR) and applicable Fiscal Laws
• Drafts and/or develops, formulates, issues and implements acquisition budget and policy related guidance.

• Responsible for the successful execution, operations and maintenance activities of participating production systems and applications.
• Support system rationalization, technology and product selection, cloud strategy and implementation, micro-services, machine learning, automation, DevSecOps, data strategy, artificial intelligence, enterprise architecture APIs.
• Provide technical guidance to customers on digital transformation and modernization, application and infrastructure migration.
• Reviews technical, architecture, data flows and design documents and provide feedback as applicable.
• Familiarity with administering system or platform in a server-based environment in the data center or in the cloud.

• Analyzes and evaluates management practices and methods, and administrative operations.
• Prepares comprehensive reports of findings and recommendations.
• Formulates and recommends additional policies and procedures or modifications to existing guidance.
• Reviews and evaluates managerial policies and procedures to determine gaps where additional guidance is needed.