Regulatory Affairs Technical Writer

Job Summary

A company is looking for a RA Technical Writer responsible for preparing and managing regulatory documents for FDA submissions related to diagnostic devices.

Key Responsibilities

• Develop and author comprehensive technical documents for PMA submissions, including device descriptions and clinical study reports
• Collaborate with cross-functional teams to gather information and ensure accuracy in all submissions
• Manage document lifecycle, including version control and preparation for electronic submissions via the FDA's eCTD system

Required Qualifications

• Bachelor's degree in a scientific or closely related field; advanced degree preferred
• 3-5 years of experience as a Technical Writer in the medical device or diagnostics industry, with FDA regulatory submissions experience
• Strong understanding of FDA regulations for Class III devices and PMA processes
• Proficiency in technical writing tools such as Microsoft Word and Adobe Acrobat
• Familiarity with CRC screening technologies or oncology diagnostics is a plus