Records Management Analyst I

HEITECH SERVICES
Onsite

About The Position

This position 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 Records Management Specialist I (Editor) primarily processes electronic documents using multiple systems. Individuals will be cross-trained to perform additional duties based on operational needs, even while assigned to specific core functions.

Requirements

  • High School Diploma required.
  • Three (3) years of related experience.
  • Two (2) years of direct document processing experience.
  • At least one (1) 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 is required.
  • Strong data entry skills with exceptional attention to detail.
  • Excellent proofreading skills with the ability to identify errors in spelling, grammar, and punctuation.
  • Strong analytical, organizational, and written communication skills.
  • Ability to maintain accuracy and productivity in a high-volume environment.

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 all 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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What This Job Offers

Job Type

Full-time

Career Level

Entry Level

Education Level

High school or GED

Number of Employees

11-50 employees

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