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 highly skilled Regulatory Affairs Contractor to support our mission of advancing early cancer detection technologies. The ideal candidate will play a critical role in navigating regulatory landscapes and ensuring compliance for our innovative diagnostic solutions.

Key Responsibilities

• Prepare and manage Investigational Device Exemption (IDE) documentation
• Develop and maintain Device Master Files (DMFs)
• Ensure compliance with In Vitro Diagnostic Regulation (IVDR) requirements
• Support regulatory submissions and interactions with regulatory bodies
• Review and update regulatory documentation to maintain alignment with current standards
• Collaborate with cross-functional teams to facilitate regulatory approvals

Qualifications

• Extensive experience in regulatory affairs within medical device or diagnostic industry
• Proven expertise in managing IDE and DMF processes
• In-depth understanding of IVDR regulatory framework
• Strong attention to detail and exceptional organizational skills
• Ability to work independently in a remote work environment

Location

Remote position, US-based candidates only