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Senior Regulatory Specialist - 58747507 - SB

Job Code: 58747507
Job Location: Maple Grove, MN
Category: Quality Engineering
Last Updated: 09/15/2017
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Job Description:
Our customer is looking for a Senior Regulatory Specialist to preparation and submission of regulatory applications, as well as internal regulatory file documentation
Assist with large new product submissions and fully own smaller submissions, e.g., 30-day notices for changes to PMA products.
Review and sign-off on product and manufacturing changes for compliance with applicable regulation (change notice reviews)
4 year degree in a Regulatory or Related fields is needed. 3+ years’ experience preparation and submission of regulatory applications, as well as internal regulatory file documentation. Must have experience and a solid understanding of what types of changes require prior approval or other types of submissions Experience writing submissions that are accurate, high quality, and easy to review/understand. Prior company experience would lower the learning curve for our change notice reviews.
For more information about this position, please contact the Entegee New Hope, MN office at 763-577-9000 or
Please reference job # 58747507SB
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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