Records Management Specialist I

HeiTech Services•Landover, MD
•Onsite

About The Position

The Records Management Specialist I (Editor) supports the Food and Drug Administration (FDA) by responding to inquiries and processing electronic applications and documentation according to established Standard Operating Procedures (SOPs) and business rules. The role primarily processes electronic documents using multiple systems. Although assigned to specific core functions, the specialist will be cross-trained to perform additional duties based on operational needs. The position is onsite in Landover, Maryland, Monday through Friday from 8:30 AM to 5:00 PM. The employee must possess or be able to obtain a Public Trust Clearance.

Requirements

  • High school diploma required.
  • Three years of related experience, including two years of direct document processing experience and at least one year of office, records, or computer-based work experience.
  • Ability to type 40 words per minute with no more than two errors.
  • Proficiency in Microsoft Office and other office automation tools.
  • Familiarity with medical terminology and HIPAA regulations.
  • Strong data-entry skills and exceptional attention to detail.
  • Excellent proofreading skills, including the ability to identify spelling, grammar, and punctuation errors.
  • Strong analytical, organizational, and written communication skills.
  • Ability to maintain accuracy and productivity in a high-volume environment.
  • Must possess or be able to obtain a Public Trust Clearance.

Nice To Haves

  • Bachelor’s degree preferred.

Responsibilities

  • Process electronic documents in accordance with current SOPs and quality standards.
  • Apply appropriate procedures and interpret business rules within established guidelines.
  • Support Medical Device Reporting (MDR) activities, including proofreading documents for grammar, spelling, and punctuation; editing for clarity and accuracy; and redacting confidential patient and manufacturer information under FOIA exemptions.
  • Review adverse event reports involving medical-device injuries or fatalities, reports submitted by healthcare providers or emergency personnel, and documentation submitted to the FDA for regulatory review.
  • Ensure redactions and revisions comply with federal privacy and disclosure requirements.
  • Maintain high productivity and accuracy in a fast-paced, high-volume electronic production environment.
  • Respond to inquiries and process electronic applications and documentation.
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