Records Management Specialist I

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.

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; 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 [email protected].

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.