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Food and Drug Administration

Biomedical Engineer

Full-time

Anywhere in the U.S. (rem...

Engineering

2 days ago

This position(s) is located in the Food and Drug Administration (FDA.....

This position(s) is located in the Food and Drug Administration (FDA), Center for Devices and Radiological Heath (CDRH), Office of Product Evaluation and Quality, Office of Regulatory Programs (ORP). This is a remote position.
ORP develops policy and provides support across all regulatory programs conducted within OPEQ.
ORP performs cross-cutting analysis to assess the performance of programs, develops tools that aid in evaluating the safety and quality of devices and electronic products, and continually monitors the state of regulated industry.
ORP programs strive to amplify and improve the impact that Center activities have on patients by facilitating accurate, consistent and timely assessment of medical and other technology over its full life.
ORP staff provide programmatic expertise; develop regulatory policy, processes, and tools; provide interpretations of regulatory requirements; and address novel or complex policy exceptions encountered during reviews.
Staff conduct program analysis and quality control activities for programs for purposes of ensuring consistency across OPEQ components and continually improving upon CDRH regulatory programs.
ORP also provides technical and logistical support on document control and automated systems which support the review activities performed across OPEQ and CDRH.
As a Senior Scientist in the ORP, you will develop regulatory programs and policies development for entities across CDRH engaged in the review of medical devices and radiological products;
Apply knowledge of scientific methodology and the application of science to ensure scientific consistency and validity of policy-related documents; and
Serve as a subject matter expert in legal, regulatory, and scientific matters related to the review and authorization of medical devices and electronic products.

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Food Safety and Inspection Service

Supervisory Program Manager (Executive Communications Branch Chief)

Full-time

Anywhere in the U.S. (rem...

Information Technology

1 week ago

Manages a team and develops information policies and programs in sup.....

Manages a team and develops information policies and programs in support of FSIS goals to a variety of internal and external stakeholders in a variety of media.
Works closely with the DECS director in developing and administering FSIS-wide executive communication strategies to inform stakeholders, including consumers, industry, academia, and the general public, of FSIS.
Ensures that communication activities are consistent with and support OPACE and FSIS long-range plans, including the annual performance plan, strategic plans, budget plans and performance plans.
Provides advice for the development and implementation of policies, plans, and programs that have a significant effect on the FSIS’s ability to effectively communicate and engage with a wide variety of stakeholders.
Ensures compliance with all relevant laws, regulations, and guidelines for internal communication, correspondence, and stakeholder engagement, including virtual, hybrid, and in-person events.
Assigns writing tasks, sets team priorities, and ensures accurate reporting of the status for significant folders going through clearance.
Provides content, editorial review, and oversight for the weekly employee newsletter, employee User Notices, invitations to external stakeholders, and other critical FSIS materials.
Assists with the preparation, presentation, and communication of FSIS-related information.
Participates in critical meetings and produces a cogent memorandum of facts/events, assesses action required and contributes towards completing staff goals.
Coordinates strategies that support FSIS’s communication with its employees, working to improve sentiments based on employee feedback, and to improve the agency’s engagement and reputation with external stakeholders.

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Food Safety and Inspection Service

Supervisory Program Manager (Digital Communications Branch Chief)

Full-time

Anywhere in the U.S. (rem...

Information Technology

1 week ago

Provides advice and oversight for the development and implementation.....

Provides advice and oversight for the development and implementation of website policies, plans, and programs that have significant effect on FSIS' ability to communicate and engage with stakeholders.
Applies and ensures compliance with all relevant laws, regulations, and guidelines for digital communications, including Federal websites.
Assigns content tasks, technical tasks, sets team priorities, and works in conjunction with staff to ensure goals are met.
Manages a team and develops information policies and programs in support of FSIS goals of internal and external stakeholders in a variety of media.
Reviews a variety of documents prepared by others that involve a wide variety of subject matter experts.
Ensures that communication activities are consistent with and support OPACE and FSIS long-range plans, including the annual performance plan, strategic plans, budget plans and performance plans.
Reviews and evaluates operations to make work assignments; assesses and enhances program and policy efficiency and effectiveness, and/or recommends improvements.
Participates in critical meetings and produces a cogent memorandum of facts/ events assesses action required and contribute towards completing goals.
Coordinates activities and conceptualizes and implements strategies that create a dynamic web presence and leverage digital assets and messaging through other communication channels.
Works closely with the DECS director in developing and administering FSIS- wide digital communication strategies to inform stakeholders, consumers and the general public of FSIS priorities and information.

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Food Safety and Inspection Service

Deputy Director

Full-time

Anywhere in the U.S. (rem...

Others

1 week ago

Manages a system for ensuring responses to FOIA/PA requests are comp.....

Manages a system for ensuring responses to FOIA/PA requests are complete, consistent, and timely.
Monitors incoming FOIA/PAs to identify issues of importance to FSIS and to ensure coordinated responses.
Assist with the development, implementation, and management of processes that ensure accurate implementation of the Freedom of Information Act (5 U.S.C. 552) and the Privacy Act of 1974 (5 U.S.C. 552a) throughout FSIS.
Writes and/or edits information on Records Management- programs, policies, functions, and research.
Participates with the OPACE Assistant Administrator (AA) and Deputy AA in developing systems for effective records management and retention plans.
Provides indirect technical guidance over those in other offices throughout FSIS who are engaged in record searches for the office.
Plans work and determines approaches; makes assignments; oversees execution; established deadlines; provides administrative and technical guidance.
Makes recommendations on major issues such as organizational goals, challenges to organizational design, or the overhaul of conventional practices to meet new challenges.
Works closely with the FOIAS Director in the planning, developing, implementing, and evaluating the strategies for FSIS Records Management.
Directs/oversees the development of long-range strategic goals, policies and procedures, records retention schedule, and transfer of records, etc.
Evaluates and analyzes requests and communicates FSIS positions to officials representing law firms, labor union officials, media, industry organizations, and privately held companies.
Assesses and enhances program and policy efficiency and effectiveness and makes, coordinates and/or recommends improvements.

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Food Safety and Inspection Service

Management Analyst

Full-time

Anywhere in the U.S. (rem...

Others

1 week ago

Responsible for ongoing and special administrative duties and evalua.....

Responsible for ongoing and special administrative duties and evaluate projects assigned by the supervisor or initiated by the employee to meet management and technical staff needs and the necessary coordination, liaison, and correspondence.
Provide support to technical staff utilizing analytical expertise and technical skills for the collection, review, analysis and information coordination of World Trade Organization (WTO) notifications to the U.S. that impacts FSIS.
Practices intense organizational and planning skills by assisting leadership and technical staff to achieve FSIS mission and vision with the integration of regulatory, inspection, and enforcement programs for food safety and procedures.
Assists technical staff with managing and organizing projects and associated data related to day-to-day internal technical engagements and operations with a focus on food safety related activities to ensure organizational support.
Applies working knowledge and understanding of information technology data systems and networks, for purposes of day-to-day technical information management and tracking and provide guidance to staff on use of these systems.
Assists management and technical staff with technology and information management at internal and external meetings and conferences, using group meeting software.
Assists the OIC in the planning and execution of in person and virtual meetings and events, including managing virtual presentations using information technology systems.
Forecasts international developments potentially affecting FSIS programs from WTO notifications and contacts and coordinates findings and recommendations with other interested/affected FSIS Offices and technical experts
Prepares findings, reports, briefing papers and other written materials regarding international food safety public health issues impacting FSIS on behalf of OIC management and technical staff.
Assists the office by creating and developing talking points, PowerPoint presentations, correspondence, and other written materials in support of OIC technical projects and operations to assist with the operations of the office.
Remains aware of any FSIS food safety updates that may impact OIC and international food safety and assists in creating and providing training or webinars on behalf of technical staff for outside stakeholders.
Exercises a broad knowledge of administrative services software and data tracking systems to assist with the organization and tracking of all office projects, information, and correspondence.
Develops sources of information for WTO notifications; identifies and performs analyses of the foreign country issues; analyzes the consequences and prepares and delivers written responses to assist in US reporting requirements.