Regulatory Affairs Specialist II
6201 South Freeway Fort Worth, TX 76134 US
Job Description
Target Pay Rate:Â 48.19-56.41Â **salary will be commensurate with experienceÂ
Job Description:
Must Haves:
ED MDR
Medical Devise Regulatory experience
Bachelor's Degree (no specific field of study)
Interviews: 2 rounds of interview.
•           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.
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