Medical Device Software Quality Manager

10 hours ago


Stockholm, Stockholm, Sweden Qbtech Full time

At Qbtech, we're committed to transforming healthcare by providing innovative solutions for ADHD diagnosis and treatment. We're now seeking an experienced System Quality Regulatory Manager to join our team and contribute to our mission.

In this role, you'll be responsible for ensuring our Quality Management System (QMS) remains compliant with regulatory requirements, including ISO 13485, 21 CFR 820, and EU-MDR 2017/745. You'll work closely with the Product Development Team to ensure compliance when designing, developing, and maintaining medical devices.

To be successful in this position, you'll need significant experience in Quality Management, Medical Device Software Development, and regulatory affairs. Strong communication and problem-solving skills are essential for achieving our goals.



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