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Regulatory Affairs Manager
Responsible for management of regulatory submissions and ongoing regulatory compliance for product development process.   Duties: Prepare and submit global regulatory applications, including U.S. Medical submissions (Pre· Submissions, 510ks, IDEs and applicable supplements and annual reports), Canadian Class 2 Device License submissions, EU MDR Submissions, and other International markets such as Japan, the Far East, Australia and Latin Review device labeling (Including IFU) and advertising materials for compliance with global regulations; analyze and recommends appropriate Review and signoff on design and manufacturing changes for compliance with applicable Support quality system audits by notified bodies, government agencies and


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