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Compliance Engineer
Regulatory /Medical Device/Quality procedures
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Location: Maple Grove, MN
Pay Rate: Contract: 45.91 to 55.35 $/hr
Salary: 95.49 to 115.13 K$/yr
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Position Type/ Job Duration: Contract 4 - 6 months
Education Required: Associates Degree 
Years Experience Required: 5

Industry:
Medical
Job Posted: 12/12/2017
Should I worry about this date?
Apply Deadline: 12/14/2017
Job #: 134170MKK
Job order status: Client is actively seeking candidates
Relocation available: Not Available


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Senior Regulatory Specialist needed for full time contract position located in the Maple Grove, MN area. This role will be responsible for preparation and submission of regulatory applications and documentation. Additionally, this role will review and sign-off on product and manufacturing changes while maintaining compliance with Quality Policy.

Responsibilities

  • Responsible for 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).
  • Maintain compliance to the Quality Policy and all other documented quality processes and procedures.

Requirements

  • 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.

Benefits

  • Competitive benefits package.
 
 
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