What are the responsibilities and job description for the Quality Assurance / Regulatory Assurance Manager position at Optalmed, LLC.?
Act as Management Representative per EN ISO 13485
● Act as PRRC per EU MDR
● Ensures that the Quality System requirements are established, implemented, and maintained
● Maintain current knowledge of federal and state regulations regarding QMSR, EN ISO 13485, EU MDR, and other quality assurance and regulatory issues
● Manage the implementation of quality system and ensure that all company employees comply with the
quality system and process specifications
● Determine worldwide regulatory strategy for devices and manage regulatory submissions and approvals for all devices
Medical Devices Manufacturing Company