System Regulatory Expert

12 hours ago


Stockholm, Stockholm, Sweden QBtech AB Full time

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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