Records Management Analyst I

HeiTech Services

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profile Job Location:

Landover, MD - USA

profile Monthly Salary: Not Disclosed
Posted on: 4 days ago
Vacancies: 1 Vacancy

Job Summary

This position supports our customer 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 Records Management Specialist I (Editor) primarily processes electronic documents using multiple systems. While assigned to specific core functions individuals will be cross trained to perform additional duties based on operational needs.


Work Location: Onsite Landover MD
Schedule: Monday through Friday 8:30 AM 5:00 PM

Security Clearance: Must possess or be able to obtain a Public Trust Clearance.


Key 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

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

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.
Requirements

Requirements

  • High School Diploma required; Bachelors degree preferred.
  • Three (3) years of related experience including:

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.


HeiTech Services is an Equal Opportunity Employer. We consider all qualified applicants without regard to race color religion sex (including pregnancy sexual orientation gender identity) national origin age disability veteran status or any other protected status. If you need a reasonable accommodation during the application process please contact


Required Experience:

IC

This position supports our customer 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 Records Management Specialist I (Editor) primarily...
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