We are redirecting you to the source. If you are not redirected in 3 seconds, please click here.

Regulatory Affairs Software Quality Engineer at Jobgether. 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. You'll be instrumental in regulatory compliance and software quality, collaborating with a team of engineers and clinicians dedicated to transforming radiation therapy. Ideal for professionals with strong programming, quality systems, and analytical experience, this role combines purpose, autonomy, and cutting-edge technology in a mission-driven environment.. . Accountabilities:. . Develop and validate non-product software tools to support internal regulatory and quality system functions.. . Translate product requirements into detailed test cases and conduct thorough testing processes.. . Collaborate cross-functionally to improve quality systems and ensure compliance with global medical device regulations.. . Leverage advanced programming skills (Python, JavaScript, C#) to create automation tools and data dashboards.. . Perform data aggregation and analysis to track KPIs and support business decisions.. . Participate in risk management activities such as FMEA, FMECA, or FTA.. . Contribute to continuous improvement of quality processes and documentation practices.. . . Bachelor’s degree with over 4 years of experience or Master’s degree with over 2 years of experience in medical device product development, quality engineering, or quality systems management.. . Strong programming background in languages such as Python, JavaScript, or C#.. . Proven ability to validate non-product software tools and develop robust test plans.. . Familiarity with global medical device regulatory standards.. . Experience with data analysis, KPI tracking, and dashboard creation.. . Excellent organizational, analytical, and problem-solving skills.. . Comfortable working remotely with strong interpersonal and communication skills.. . Preferred: Experience with DICOM, Radiation Oncology workflows, and Software as a Medical Device (SaMD).. . . Company Location: United States.