Records Management Analyst I

HEITECH SERVICES•Landover, MD
•Onsite

About The Position

This position supports the Food and Drug Administration (FDA) by responding to inquiries and processing electronic applications and documentation in accordance with established Standard Operating Procedures (SOPs) and business rules. The role primarily processes electronic documents using multiple systems. Although assigned to specific core functions, the employee 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.
  • Perform Medical Device Reporting (MDR) support activities, including proofreading documents for grammar, spelling, and punctuation; editing for clarity and accuracy; and redacting confidential patient and manufacturer information in accordance with FOIA exemptions.
  • Review adverse event reports involving injury or fatality related to medical devices, 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 electronic production environment.
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