Regulatory Affairs Quality Engineer

Job Summary

A company is looking for a Regulatory Affairs Software Quality Engineer.

Key Responsibilities

• Validate 3rd party and internally developed tools
• Create custom tools for internal use and automate data collection and reporting
• Update software and cyber-related documentation for agency submissions

Required Qualifications

• Bachelor's degree with 4+ years of experience or Master's degree with 2+ years of experience in related roles
• Experience with Non-Product Software Tool Validation
• Ability to develop software tools using programming languages such as Python, JavaScript, or C#
• Familiarity with global medical device regulations and experience in data analysis
• Demonstrated ability to work productively in a remote environment