Document Specialist, IVD Compliance

Job Summary

A company is looking for a Document Specialist, Lab & Manufacturing Ops.

Key Responsibilities

• Support the creation, organization, maintenance, and lifecycle management of controlled documentation (DHF) and associated documents
• Partner with Quality to ensure documentation compliance with regulatory requirements and internal quality management system standards
• Conduct gap assessments to identify compliance risks and improvement opportunities

Required Qualifications

• Master's degree in Quality Management Systems
• Bachelor's degree in Life Sciences, Engineering, Quality, Regulatory Affairs, or a related discipline
• 3-5+ years of document control or quality documentation experience in a regulated environment
• Working knowledge of FDA 21 CFR Part 820, ISO 13485, and CLIA lab documentation
• Experience supporting Design History Files (DHF) and technical files generated by Laboratory and Manufacturing Operations teams