Hybrid Lead Regulatory Data Specialist na Zimmerman Associates, Inc.

Job Title: Lead Regulatory Data Specialist
Location: Fairfax, VA (Onsite)
Company: Zimmerman Associates, Inc.
Job Type: Full-Time
Industry: Records Management / Regulatory Compliance

About the Role:

Zimmerman Associates, Inc. (ZAI) has an immediate opening for a Lead Regulatory Data Specialist to support one of our critical Records Management operations in Fairfax, VA. This role is ideal for an experienced professional with a strong background in regulatory data review, quality assurance, and project documentation. You will be responsible for reviewing inspection data, generating reports for potential violations, and ensuring all project deliverables meet quality standards in compliance with FDA regulations.

Key Responsibilities:

• Generate inspection summary reports and recommend enforcement actions such as warning letters or civil monetary penalties.

• Review inspector-submitted data for accuracy, completeness, and consistency; identify possible violations.

• Implement and manage a project quality assurance plan, ensuring process adherence and objective alignment.

• Sample output products/processes and compare against project specifications; recommend and document corrective actions.

• Utilize FDA software systems to review and code tobacco retail inspection data.

• Accurately enter and verify information from inspection forms/images into FDA databases using FDA terminology.

• Retrieve and match system output with specifications per SOPs, resolving any discrepancies.

• Provide mentorship or assistance to lower-level team members and cross-train staff as needed.

• Conduct quality assurance reviews of data entered into the FDA system.

• Provide performance feedback to Regulatory Data Specialists and data entry staff.

• Collaborate with a Sr. Quality Control Analyst and other team leads.

• Physically deliver documents to a local UPS facility in accordance with project deadlines.

• Lift up to 20 lbs as part of project duties.

Qualifications:

• Bachelor’s Degree preferred.

• Minimum 4 years of related experience in regulatory review, quality control, or similar roles.

• Familiarity with quality control techniques and regulatory data review processes.

• Strong proficiency in Microsoft Excel and MS Office Suite.

• Experience working with databases and FDA systems preferred.

• Strong attention to detail and ability to follow detailed procedures and documentation standards.

Equal Opportunity Employer Statement

Zimmerman Associates, Inc. (ZAI) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, veteran status, or any other legally protected status.

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