FDA Regulation Documentation Specialist

Overview

On Site
$20 - $30
Contract - W2
Contract - 3 Month(s)

Skills

ISO 9000
ISO 13485

Job Details

This role focuses on managing and maintaining Quality Management System (QMS) documentation in compliance with ISO and FDA regulations (ISO 9001, ISO 13485, 21 CFR 820). The person will handle document creation, review, change control, and retention, while supporting audits, CAPAs, and continuous improvement initiatives. The position is best suited for someone with strong attention to detail, quality system knowledge, and experience in regulated manufacturing or life sciences environments.

Key Responsibilities

  • Create, review, and maintain quality system documents (procedures, work instructions, certificates).

  • Manage document control processes including change controls and approvals.

  • Collaborate with teams to ensure compliant processes and procedures.

  • Support audits, CAPAs, and continuous improvement projects.

  • Ensure proper document distribution and retention.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

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