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Regulatory Affairs Specialist - 63108694 - TT

Job Code: 63108694
Job Location: Mounds View, MN
Category: Quality Engineering
Last Updated: 12/21/2018
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Job Description:
The Regulatory Affairs Specialist (w/ history of successful device submissions) will provide global support for medical devices, is responsible for activities that lead to and maintain regulatory approval/clearance of these devices, (EU MDR) and assesses the regulatory implications of changes to these devices.  
• Prepare technical dossiers for initial and renewal submissions within the European Union. Compile the necessary information and deliverables in preparation of the submissions.
• Provide support to currently marketed products, as necessary. This includes reviewing product changes, labeling changes, promotional materials, and assessing the need for regulatory agency approval/clearance prior to implementation of changes.
• Provide product information to worldwide peers for international product submissions, re-certifications, and change notifications. May support submissions to WW regulatory agencies as assigned.
• Maintain regulatory affairs product files to support compliance with regulatory requirements.
• Knowledge of word processing, spreadsheet, database and graphics presentation applications (Microsoft Office, Adobe Acrobat, Documentum, SharePoint, and SiteBuilder).
• Competency with Microsoft Office applications and Adobe Acrobat
• A BA/BS/MS/Law degree
• Experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards. History of successful device submissions
For more information about this position, please contact the Entegee New Hope, MN office at 763-577-9000 or
Please reference job # 63108694TT
Equal Opportunity Employer


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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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