Regulatory Affairs Software Quality Engineer

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).

• Competitive base salary: $100,000 – $145,000 USD (based on experience, degree, and location).
• Comprehensive medical, dental, and vision insurance for employees and dependents.
• 401(k) plan with immediate employer match.
• Self-managed PTO and generous parental leave policies.
• Fully remote work environment with part-time return-to-work options post-parental leave.
• Annual retreats, virtual events, and a supportive, collaborative team culture.
• Commitment to diversity, equity, and inclusion in the workplace.

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.
When you apply, your profile goes through our AI-powered screening process designed to identify top talent efficiently and fairly.
🔍 Our AI evaluates your CV and LinkedIn profile thoroughly, analyzing your skills, experience, and achievements.
📊 It compares your profile to the job’s core requirements and past success factors to determine your match score.
🎯 Based on this analysis, we automatically shortlist the 3 candidates with the highest match to the role.
🧠 When necessary, our human team may perform an additional manual review to ensure no strong profile is missed.

The process is transparent, skills-based, and free of bias — focusing solely on your fit for the role.
Once the shortlist is completed, we share it directly with the company that owns the job opening. The final decision and next steps (such as interviews or additional assessments) are then made by their internal hiring team.
Thank you for your interest!

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