Regulatory Program Support Specialist

SAIC · Silver Spring

The U.S. Food and Drug Administration (FDA) is seeking a highly motivated and detail-oriented Regulatory Program Support Specialist to provide critical public health and regulatory support to the Food Facility Registration and Complaint Programs. This includes supporting adverse event, product problem, and regulatory misconduct programs. The incumbent will play an integral role in protecting and advancing public health by managing program records, coordinating cross-functional activities, engaging stakeholders, and enabling effective branch operations through data management, system support, and communications.

This is a remote position supporting FDA's mission to ensure the safety, security, and effectiveness of the U.S. food supply. The successful candidate will thrive in a fast-paced, mission-driven environment and demonstrate a commitment to regulatory integrity, public health, and exceptional service delivery.

KEY RESPONSIBILITIES

Public Health & Regulatory Program Support

Provide public health and regulatory support to the Food Facility Registration and Complaint Programs, including adverse event reporting, product problem tracking, and regulatory misconduct programs.
Actively support efforts to reduce and manage review backlogs, ensuring timely processing of regulatory submissions and complaints.
Assist in the interpretation and application of applicable FDA regulations, policies, and program guidance documents.

Records Management & Information Governance

Coordinate and maintain record-keeping systems in support of regulatory program activities.
Direct document control processes, manage archives, and administer information governance practices in accordance with federal standards and FDA policies.
Collaborate across FDA offices and divisions to ensure information is accurately captured, accessible, and maintained in compliance with applicable frameworks.

Stakeholder Outreach & Coordination

Conduct outreach and coordinate with internal and external stakeholders, including consumers, industry representatives, and other public health and government entities.
Support the completion of records-related regulatory and public health activities through proactive engagement and effective communication with diverse audiences.
Serve as a liaison between program offices and external partners, facilitating the flow of information and supporting collaborative regulatory initiatives.

Branch Operations & Administrative Support

Support and advise branch operations by performing system testing to verify functionality and data integrity across FDA program systems.
Respond to internal and external inquiries in a timely, accurate, and professional manner, ensuring consistent and high-quality service.
Enter, validate, and maintain program data across regulatory databases and information systems, ensuring data accuracy and completeness.
Prepare professional presentations and develop summary documents, reports, and briefing materials for leadership and stakeholder audiences.

SAIC® is a premier mission integrator focused on advancing the power of technology and innovation to serve and protect our world. Our robust portfolio of offerings across the defense, space, intelligence, and civilian markets includes secure high-end solutions in mission IT, enterprise IT, engineering services, and professional services. We integrate emerging technology, rapidly and securely, into mission critical operations that modernize and enable critical national imperatives.

We are approximately 23,000 strong; driven by mission, united by purpose, and inspired by opportunities. SAIC is an Equal Opportunity Employer. Headquartered in Reston, Virginia, SAIC has annual revenues of approximately $7.3 billion. For more information, visit saic.com. For ongoing news, please visit our newsroom.

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