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Regulatory Specialist- 64372652TT

Job Code: 64372652
Job Location: Saint Paul, MN
Category: Quality Engineering
Last Updated: 10/11/2019
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JOB DESCRIPTION
Regulatory Specialist
 
• Draft MDR submission documents using corporate template
• Obtain content for the submission documents by reviewing currently available submission documents, pull appropriate content into new document, format appropriately, and review with BSC Reg Associate.
• Draft MDR Submission project Deliverables List using corporate template
• Use template and Deliverables List Golden Example to create a Deliverables List to be used with a new project team.
• Draft General Safety and Performance Requirements (GSPRs) using corporate templateUse template and GSPR Golden Example to create a GSPR
• Draft Declaration of Conformity (DOC) using corporate template
• Use template and GSPR Golden Example to create a DO
• Research and Upload data for Eudamed purposes
• Review regulatory submission documents to recognize and pull relevant content
• Work with Regulatory Specialists to research and gather database specific elements not included in current submission documentation
 
JOB REQUIREMENTS
• BA/BS in Life Sciences, Engineering or equivalent
• 2+years regulatory or related experience  
• Proficient in Microsoft Suite programs, as well as Teams and SharePoint
• Experience with US and Europeans regulatory submissions docs
 
Equal Opportunity Employer
Minorities/Women/Veterans/Disabled
 
For more information about this position, please contact the Entegee New Hope, MN office at
763-577-9000 or engineeringteam@entegee.com.
 
Please reference job # 64372652TT
 
 
 

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