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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.
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