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Regulatory Affairs Specialist II

Lake Forrest, CA 92630

Posted: 08/16/2024 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 613525 Is job remote?: Yes Country: United States

Job Description


Target Pay Rate: 47.50-55.61/hr **salary will be commensurate with experience 

Job Description: 
ED MDR
Medical Devise Regulatory experience
Bachelor's Degree (no specific field of study)

•            Under guidance, update technical documentation files to align with EU MDR medical device requirements

•            Submit Regulatory Impact Assessments to countries using Veeva system and ensure completeness of assessment from countries

•            Coordinate submission package and manage country timelines to support approval of lifecycle management changes for medical devices

•            Under guidance,  collect data from Technical Documentation File in preparation for Eudamed go-live

•            Verify registration data in Veeva database for US and Canada medical devices

It's a bonus if they are local to Dallas-Fort Worth and can come into the Fort Worth office periodically.


**CO/NY candidates may not be considered 
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