Regulatory Quality Assurance Manager

8 hours ago


Stockholm, Stockholm, Sweden QBtech AB Full time
About the Role

The System Quality Regulatory Manager will be responsible for ensuring the Quality Management System (QMS) is compliant with relevant regulations and standards. This includes maintaining awareness of regulatory requirements, identifying areas for improvement, and implementing changes to ensure ongoing compliance.

This role involves coordinating with cross-functional teams to ensure QMS integration across departments. The successful candidate will have a strong understanding of medical device regulations, including ISO 13485, 21 CFR Part 820, and EU-MDR 2017/745.



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