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Regulatory Affairs Specialist II

Fort Worth, TX 76134

Posted: 01/31/2025 Employment Type: Contract Job Category: Regulatory Affairs Job Number: 617453 Is job remote?: Yes Country: United States

Job Description


Target Pay Rate: 48.19-56.41 **salary will be commensurate with experience 

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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About Fort Worth, TX

Ready to embark on an exciting career journey in Fort Worth, Texas? Explore our job listings in this vibrant city known as the 'City of Cowboys and Culture.' Fort Worth offers a perfect blend of rich Western heritage and modern amenities, making it an ideal destination for job seekers looking for growth opportunities and a high quality of life. From the iconic Fort Worth Stockyards to the world-renowned Kimbell Art Museum, there is something to enchant everyone here. Indulge in mouthwatering Tex-Mex cuisine, catch a show at the Bass Performance Hall, support the revered Fort Worth Symphony Orchestra, or cheer on the Dallas Cowboys at AT&T Stadium. Come discover why Fort Worth is the perfect place to take the next step in your career and experience its irresistible charm firsthand.

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