Technical Writer

Job Summary

A company is looking for a Technical Writer.

Key Responsibilities

• Develop, edit, and maintain technical documentation and labeling for product design and distribution
• Facilitate documentation review and approval processes while acting as a liaison between project teams and the Technical Documentation Department
• Ensure compliance with regulatory standards and support audits related to documentation and labeling

Required Qualifications

• Bachelor's degree in a scientific discipline, business administration, or a related technical field
• Minimum of 5+ years of direct technical documentation experience in medical device, software, pharmaceutical, or biotechnology industries
• Demonstrated knowledge of U.S. and international regulatory standards (FDA, ISO, IVDD, 21 CFR Part 11)
• Experience supporting multiple concurrent projects in a cross-functional environment