Global Quality Regulatory Lead

13 hours ago


Stockholm, Stockholm, Sweden Qbtech Full time

Transforming healthcare is at the heart of Qbtech's vision, and we're seeking an experienced System Quality Regulatory Manager to join our global team. This role will play a vital part in ensuring the company's Quality Management System (QMS) remains compliant with relevant legislation, such as ISO 13485, 21 CFR 820, and EU-MDR 2017/745.

The successful candidate will have a deep understanding of Medical Device legislations and Qbtech's QMS requirements. They will work closely with the Product Development Team to ensure compliance when designing, developing, and maintaining medical devices. Additionally, they will perform internal and supplier audits, document and record control, and be responsible for CAPA, Change Control, Complaint, and Non-Conformances.

To be considered for this role, you should have previous experience with Medical Device Software Development, adequate scientific education, and knowledge of regulation (EU) 2017/745, US 21 CFR Part 820, and ISO 27001. You should also possess excellent communication skills, scientific skills, and the ability to interact with internal and external stakeholders.



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