![QBtech AB](https://media.trabajo.org/img/noimg.jpg)
Regulatory Compliance Specialist
13 hours ago
At Qbtech AB, you will have the opportunity to work on something meaningful that helps people understand ADHD while transforming healthcare. As a System Quality Regulatory Manager, you will lead the development of best-in-class products and services globally. You will be part of an international environment together with some of the leading experts in the world. Qbtech AB offers education and certifications in fields relevant to the technology used within the company.
Key Responsibilities
The SQR Manager will be responsible for ensuring compliance with regulations and implementing the Quality Management System correctly. They will provide support and advice to the organization, coordinate inspections and audits, and perform internal and supplier audits. The successful candidate will also be responsible for document control, CAPA, Change Control, Complaints, and Non-Conformances.
Requirements
The ideal candidate has experience in Medical Device Software Development, Quality Management, and auditing. They should have a BSc or higher degree, verbal and written English proficiency, and the ability to pass a background check. The successful candidate must have knowledge of Regulation (EU) 2017/745, US 21 CFR Part 820, ISO 13485:2016, and ISO 27001.
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