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| Assoc Regulatory Affairs Spec CO Open (J#26780) Title: Assoc Regulatory Affairs Spec Company: Medtronic Assoc Regulatory Affairs Spec Job Description Assoc Regulatory Affairs Spec Requisition 63412 Category Regulatory Affairs and QA Business Navigation Division Surgical Navigation Tech Location USA-CO-Louisville Relocation No relocation assistance Job Type Full Time - Regular Exempt/Non-Exempt Exempt Shift First Travel Percentage 0% Experience Required 2 years Education Required Associate of Science Position Description Responsible for assisting in the development, retrieval and maintenance of Regulatory documentation, RA metrics, and complaint handling. This position will work with multiple functional areas, geographies and business units to support product information requests and product registration requirements. Position Responsibilities * Acquire and maintain knowledge of the applicable regulatory, compliance, and corporate standards/requirements (FDA Quality System Regulations, European Quality Standards, ISO 13485), which apply to the MNav medical device products. * Assist in maintaining database management systems in areas of document change control, product complaint processing and reporting, and worldwide regulatory status of company products. More... | |||
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