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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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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
• 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
For more information about this position, please contact the Entegee New Hope, MN office at
763-577-9000 or
Please reference job # 64372652TT


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Entegee is an equal opportunity employer. Entegee considers applicants for all positions without discrimination on the basis of race, color, religion, sex, national origin, age, marital or veteran status, disability, or any other legally protected status. No question in the website is used for the purpose of limiting or excluding any applicant's consideration for employment on any basis prohibited by local, state, or federal law.

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