Regulatory Affairs Software Quality Engineer - Remote

Overview

This position is posted by Jobgether on behalf of Radformation. We are currently looking for a Regulatory Affairs Software Quality Engineer in the United States. Step into a role where your work directly impacts global cancer care. This fully remote position offers the opportunity to drive innovation in healthcare automation, supporting the development and validation of advanced tools that improve treatment quality and safety.

In Short

• Develop and validate non-product software tools for regulatory and quality system functions.
• Translate product requirements into detailed test cases and conduct thorough testing.
• Collaborate to improve quality systems and ensure compliance with regulations.
• Leverage programming skills (Python, JavaScript, C#) for automation tools.
• Perform data aggregation and analysis for KPIs and business decisions.
• Participate in risk management activities (FMEA, FMECA, FTA).
• Contribute to continuous improvement of quality processes.

Requirements

• Strong programming skills in Python, JavaScript, and C#.
• Experience in regulatory affairs and software quality.
• Analytical skills for data analysis and KPI tracking.
• Familiarity with medical device regulations.
• Experience in quality systems and documentation practices.

Benefits

• Fully remote work environment.
• Opportunity to impact global healthcare.
• Work with a dedicated team of engineers and clinicians.
• Access to cutting-edge technology.
• Autonomy in your role.