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Role Overview:
The Quality Assurance and Regulatory Compliance Manager will play a critical role in maintaining and optimizing the Quality Management System (QMS) to ensure compliance with ISO 13485, MDR, and FDA regulations. This position involves establishing and overseeing processes such as Change Control and CAPA, developing metrics to identify areas for improvement, and leading the Risk Management team in accordance with ISO 14971.
Responsibilities:
- Maintain and enhance the QMS to ensure regulatory compliance
- Establish and oversee Change Control and CAPA processes
- Develop metrics to proactively identify areas for improvement and initiate necessary actions
- Lead the Risk Management team in accordance with ISO 14971
