Medical Device Regulatory Compliance Expert
7 dagen geleden
**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**
- Develop and maintain quality management systems to ensure compliance with regulatory standards.
- Collaborate with cross-functional teams to manage quality processes and documentation.
- Ensure timely completion of test protocols and reports.
- 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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