Remote Regulatory Programs Specialist Public Health Records

SAIC; Silver Spring (MD); Remote; USD 80,000 - 120,000; Full time

Job summary

The FDA is seeking a Regulatory Program Support Specialist to provide essential public health and regulatory support for Food Facility Registration and Complaint Programs. The role involves managing records, coordinating cross-functional activities, and engaging stakeholders to enable efficient branch operations.

Responsibilities include backlogs reduction, interpretation of FDA regulations, and maintaining information governance across regulatory databases.

Qualifications

• Bachelor’s degree in Public Health, Health Sciences, Life Sciences, Business Administration, Information Management, or a closely related field is required.
• Master's degree in a relevant discipline (e.g., Public Health, Health Informatics, Regulatory Affairs) is preferred.
• 3–5 years of experience in regulatory program support, public health, records/information management, or related field.
• Experience managing regulatory records, document control, or compliance activities in a government or highly regulated environment.
• Proficiency in document control, records management, and information governance practices; knowledge of federal records management standards is a plus.
• Ability to enter, maintain, and validate data in electronic information systems with high accuracy.
• Strong analytical and organizational skills; capability to prepare clear summaries, reports, and presentations.
• Ability to collaborate across organizational boundaries in a remote work environment.

Responsibilities

• Provide public health and regulatory support to FDA programs including adverse event reporting and regulatory misconduct programs.
• Support efforts to reduce review backlogs and ensure timely processing of submissions and complaints.
• Interpret and apply FDA regulations, policies, and program guidance documents.
• Coordinate and maintain record-keeping systems and administer information governance practices.
• Collaborate with FDA offices and divisions to ensure information is accessible and compliant.
• Conduct outreach with consumers, industry representatives, and public health entities; communicate effectively with diverse audiences.
• Serve as liaison between program offices and external partners to support regulatory initiatives.
• Support branch operations by testing systems and ensuring data integrity across FDA program systems.
• Prepare presentations and develop briefing materials for leadership and stakeholders.

Skills

Regulatory program support

Data entry accuracy

Cross-functional collaboration

Microsoft Office proficiency

Communication

Education

Bachelor's degree in Public Health/Health Sciences/ Life Sciences

Master's degree in Public Health/Health Informatics/Regulatory Affairs

Tools

Regulatory tracking tools

Electronic information systems

Document control systems

Job description

The FDA is seeking a Regulatory Program Support Specialist to provide essential public health and regulatory support for Food Facility Registration and Complaint Programs. The role involves managing records, coordinating cross-functional activities, and engaging stakeholders to enable efficient branch operations.

Responsibilities include backlogs reduction, interpretation of FDA regulations, and maintaining information governance across regulatory databases.