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Regulatory Specialist - 64250606 - TT

Job Code: 64250606
Job Location: Maple Grove, MN
Category: Quality Engineering
Last Updated: 01/23/2019
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Job Description:
Our customer is looking for Regulatory Affairs Specialist to Peripheral Interventions Regulatory Affairs group to prepare Technical Files and Design Dossiers for the new EU Medical Device Regulation (MDR).  Transferring existing Technical File and Design Dossier content into new EU MDR templates. Performing a “state of the art” gap assessment of existing files to current EN ISO standards and company SOP revisions.
 
Requirements:
• Bachelor’s degree in a scientific or technical discipline
• Working knowledge of EU directives and regulations
• Proficient in preparing EU Technical Files and Design Dossiers
• Proficiency with Microsoft Word, Excel and PowerPoint
• Effective written and oral communication, technical writing, and editing skills
• Ability to work independently with minimal supervision
• Develops and maintains positive relationships with regulatory specialists to coordinate technical documentation updates for the new EU Medical Device Regulation
• Working knowledge of FDA and international regulations
• Developing and implementing regulatory strategy for medical devices, especially as it relates to the EU
• General understanding of product development process and design control
• Ability to manage several projects within assigned timelines
 
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 # 64250606TT
 
Equal Opportunity Employer
Minorities/Women/Veterans/Disabled
 
 

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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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