Company Overview

We are a pioneering cancer detection company dedicated to transforming early cancer diagnosis through innovative non-invasive blood testing technologies. By leveraging cutting-edge epigenomic platforms and artificial intelligence, we aim to enable individuals at risk of high-mortality cancers to live longer, healthier lives.

Position Summary

We are seeking a meticulous Document Control Specialist to manage and maintain our critical documentation systems. The ideal candidate will ensure the accuracy, accessibility, and compliance of our regulatory and technical documentation across all organizational levels.

Key Responsibilities

• Manage and maintain document control systems in compliance with industry regulations
• Implement and oversee document review, approval, and distribution processes
• Maintain version control for technical documents, standard operating procedures (SOPs), and regulatory submissions
• Coordinate document reviews and approval workflows across multiple departments
• Ensure electronic and physical document archives are organized, secure, and easily retrievable
• Support audit preparations by maintaining comprehensive and up-to-date documentation
• Track and manage document change requests and revisions
• Implement and maintain document management software and tracking systems

Qualifications

• Bachelor's degree in Business Administration, Information Management, or related field
• Minimum 2-3 years of experience in document control, preferably in medical device, biotechnology, or pharmaceutical industries
• Strong understanding of regulatory documentation requirements (FDA, ISO 13485, IVDR)
• Proficiency in document management software and enterprise content management systems
• Exceptional organizational and attention to detail skills
• Strong communication and interpersonal abilities
• Ability to work independently and collaborate effectively in a team environment

Technical Skills

• Advanced proficiency in Microsoft Office Suite
• Experience with electronic document management systems
• Knowledge of quality management principles
• Familiarity with regulatory documentation processes

Location

Remote position, US-based candidates only