
System Regulatory Compliance Expert
4 days ago
Advancing Quality in Medical Devices
We are seeking a talented Medical Device Quality Lead to join our team at QBtech AB.
The successful candidate will be responsible for maintaining and updating our Quality Management System (QMS) in accordance with relevant legislation and ensuring its correct implementation at our headquarters and subsidiaries in Europe and the USA.
Main ObjectivesThe main objectives of this role include:
- To ensure compliance with relevant legislation and regulatory requirements.
- To provide expert knowledge in Qbtech Management Systems, including ISO 13485, 21 CFR 820, ISO 27001, EU-MDR 2017/745, and other country-specific medical device legislations.
- To collaborate with the Product Development Team to ensure compliance with Medical Device legislations and Qbtech QMS requirements.
- To perform internal and supplier audits.
- To ensure document and record control.
- To manage CAPA, Change Control, Complaints, and Non-Conformances.
- To provide training in quality and regulatory matters.
- To act as deputy to the QARA Manager in headquarters and/or QARA Manager at QBtech US site.
- Relevant experience in Medical Device Software Development.
- Scientific education, BSc or higher.
- Experience in Quality Management in accordance with ISO 13485 and US 21 CFR Part 820.
- Excellent verbal and written English proficiency.
- Able to pass a background check.
At QBtech AB, you will have the opportunity to work on meaningful projects that help people understand ADHD while transforming healthcare. You will collaborate with international experts, lead the development of best-in-class products and services, and enjoy opportunities for learning and growth.
This role has a hybrid remote setting, with at least 3 days in the Stockholm office per week. Some domestic and international travel is required.
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