GENERAL SUMMARY The post-market Regulatory Affairs Engineer works within a team of Regulatory Affairs professionals to ensure compliance with country specific regulatory requirements for post market surveillance including complaints handling, adverse event reporting, as well as field actions. This role will have significant visibility and a chance to make a real difference to our employees and our customers as we add value through post market insights. You will implement standard mechanisms for timely handling, assessment and disposition of customer complaints, potential reportable events and field actions, and ensure timely report submission to regulatory agencies, such as MDR. In addition, you will participate in CAPA activities to drive
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The Institute for Operations Research and the Management Sciences
5521 Research Park Drive, Suite 200 Catonsville, MD 21228 USA