Medical Device Regulatory Compliance Expert

7 dagen geleden


Den Haag, Zuid-Holland, Nederland Corsano Health Voltijd

**Job Summary**

We are seeking a talented QARA Engineer to implement and maintain our Quality Management System (QMS) compliant with ISO 13485, IEC 62304, and EU Medical Device Regulation requirements.

**Key Responsibilities**

  1. Develop and maintain quality management systems to ensure compliance with regulatory standards.
  2. Collaborate with cross-functional teams to manage quality processes and documentation.
  3. Ensure timely completion of test protocols and reports.
  4. Provide training on quality and regulatory processes.

**Requirements**

  • Masters degree in Engineering or related field.
  • 3+ years of experience in quality assurance within the medical device industry.
  • Experience with software as a medical device (IEC 62304) is a strong advantage.
  • Proficiency with document control systems and QMS software.


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