Records Management Specialist I

Heitech Services; Landover (MD); On-site; USD 52,000 - 62,000; Full time

Job summary

HeiTech Services, Inc. is seeking a Records Management Specialist I (Editor) to support FDA inquiries and process electronic documents in accordance with SOPs and business rules.

The role involves editing for clarity, redacting sensitive information per FOIA, and ensuring accuracy in a fast-paced electronic production environment. The position is onsite in Landover, MD, with a 8:30 AM–5:00 PM schedule, and requires either a High School Diploma or a Bachelor’s degree with at least three years of

Qualifications

• High School Diploma required; Bachelor’s degree preferred.
• Three (3) years of related experience, including two (2) years of direct document processing.
• 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 ability to identify errors.

Responsibilities

• Process electronic documents per SOPs and quality standards.
• Apply procedures and interpret business rules within guidelines.
• MDR support: proofreading, editing for clarity, redacting information per FOIA exemptions.
• Review Adverse Event Reports related to medical devices and regulatory submissions.
• Ensure redactions and revisions comply with privacy and disclosure rules.
• Maintain high productivity and accuracy in a fast-paced electronic environment.

Skills

Typing 40 wpm

Attention to detail

Proofreading

Written communication

Data entry

Analytical ability

Medical terminology

HIPAA knowledge

Education

High School Diploma

Bachelor’s degree preferred

Tools

Microsoft Office

Job description

Description

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.

This 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

• High School Diploma required; Bachelor’s 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, and gender identity), national origin, age, disability, veteran status, or any other protected status under applicable law.

If you require a reasonable accommodation during the application process, please contact us at [e-mail].

HeiTech Services may utilize technology-assisted tools, including artificial intelligence, to support the review of application materials. These tools are used to enhance efficiency; however, all hiring decisions are made by human reviewers in accordance with federal hiring guidelines.