Key skills
Cyber Security
About this role
Role Overview
- Work cross-functionally to align quality and regulatory requirements throughout the medical device software lifecycle
- Support the qualification and validation of digital tools and systems used within the QMS
- Lead the implementation, maintenance, and user training of Qbtech’s eQMS system
- Support the development and implementation of regulatory strategies
- Perform internal audits and follow up on proposed improvements
- Support companywide and employee specific training initiatives
- Act as deputy to the Project Quality & Regulatory Manager.
Requirements
- 7+ years in regulatory/quality roles for medical device software
- Expertise in IEC 62304, ISO 13485, ISO 14971, EU MDR, FDA QMSR
- Knowledge of software development, cybersecurity, and medical software architecture
- Experience with international regulatory submissions.
Tech Stack
- Cyber Security
Benefits
- Hybrid work, minimum 3 days/week in Stockholm.