Tech Stack

Description

In this role, you will manage and organize critical documentation across preclinical, manufacturing, engineering, quality, and regulatory departments to support compliance and readiness for audits. You'll maintain document control systems, archives, and improvement processes in a fast-paced medical device environment.

Requirements

• Meticulous attention to detail and exceptional organizational skills
• Excellent verbal and written communication skills
• Strong multitasking in dynamic, fast-paced environment
• Proficiency with Google Suite and document management tools
• Working knowledge of medical, scientific, and regulatory terminology

Responsibilities

• Sustain and improve document control systems aligning with FDA regulations and GxP requirements
• Organize GxP files into traceable, searchable systems
• Maintain archives for GxP studies and lead re-indexing projects
• Assist in SOP development, revisions, and periodic reviews
• Manage document lifecycles: versioning, deprecation, and approval workflows