Regulatory Affairs Specialist II
20521 Lake Forest Dr, Lake Forest, CA 92630 Lake Forrest, CA 92630 US
Job Description
Target Pay Rate: 47.50-55.61/hr **salary will be commensurate with experienceÂ
Job Description:Â
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 consideredÂ
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