Regulatory Program Support Specialist

This is a fully remote position, open to applicants in Maryland.

📋 Description

• Provide support in public health and regulatory matters for the Food Facility Registration and Complaint Programs, encompassing adverse event reporting, product issue tracking, and regulatory misconduct initiatives.

• Assist in efforts to minimize and manage review backlogs, ensuring prompt processing of regulatory submissions and complaints.

• Aid in interpreting and applying FDA regulations, policies, and guidance documents related to programs.

• Coordinate and uphold record-keeping systems that support regulatory program operations.

• Oversee document control processes, manage archival systems, and implement information governance practices in accordance with federal standards and FDA policies.

• Collaborate with various FDA offices and divisions to ensure accurate information capture, accessibility, and compliance.

• Engage in outreach and coordination with consumers, industry representatives, public health organizations, and government stakeholders.

• Act as a liaison between program offices and external partners.

• Conduct system testing to confirm functionality and data integrity across FDA program systems.

• Respond to both internal and external inquiries with accuracy and professionalism.

• Enter, validate, and maintain program data within regulatory databases and information systems.

• Develop presentations, summary documents, reports, and briefing materials for leadership and stakeholder audiences.

⛳️ Requirements

• A Bachelor's degree in Public Health, Health Sciences, Life Sciences, Business Administration, Information Management, or a closely related field is required.

• A minimum of three (3) to five (5) years of experience in regulatory program support, public health, records/information management, or a directly related field.

• Proven experience in managing regulatory records, document control, or compliance-related activities within a government or highly regulated environment.

• Proficient in document control, records management, and information governance practices.

• Demonstrated ability to enter, maintain, and validate data in electronic information systems or regulatory databases with a high level of accuracy.

• Strong analytical skills to interpret program data, identify trends, and create clear and concise summary documents, reports, and presentations.

• Proven capability to collaborate effectively across organizational boundaries in a remote work setting, manage competing priorities, and adapt to changing program needs.

• Exceptional attention to detail in reviewing, entering, and managing regulatory records and program data.

• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

• A Master’s degree in a relevant discipline is preferred.

• Familiarity with federal records management standards, experience with federal information systems, case management platforms, or regulatory tracking tools, project management experience, federal government or federal contract experience, and knowledge of FDA regulations, food safety frameworks, complaint programs, or similar federal public health regulatory programs are preferred or advantageous.

🏝️ Benefits

• Remote work

• Reliable internet access and a suitable home office environment

• Availability during core FDA business hours (Eastern Time)

• Occasional virtual meetings or training sessions outside standard hours