
System Regulatory Expert
12 hours ago
Quality and Regulatory Expertise
QBtech AB is searching for a seasoned System Quality Regulatory Manager with extensive experience in quality management systems, particularly in the medical device industry. The ideal candidate will possess a deep understanding of regulations such as ISO 13485, 21 CFR 820, and EU-MDR 2017/745, as well as exceptional communication and collaboration skills.
Key Responsibilities
- Maintain the Quality Management System (QMS) in compliance with relevant legislation and industry standards.
- Act as the host during inspections and audits by notified bodies and authorities.
- Collaborate with the Product Development Team to ensure compliance with Medical Device legislations and Qbtech QMS requirements.
- Deliver expert advice on Qbtech Management Systems and support the organization in fulfilling regulatory requirements.
Qualifications
- Adequate scientific education, BSc or higher.
- Excellent verbal and written English proficiency.
- Ability to pass a background check.
We Provide
At QBtech AB, you will be part of a dedicated team working tirelessly to bring innovative solutions to patients worldwide. We offer numerous opportunities for growth, professional development, and education, as well as a supportive work environment that encourages collaboration and mutual respect.
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