Regulatory Affairs Coordinator

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  • As an Equal Employment Opportunity Employer, DAVIS has reporting requirements which require us to invite employees to voluntarily self-identify their race/ethnicity. Submission of this information is voluntary and refusal to provided it will not subject you to any adverse treatment. The information obtained will be kept confidential.
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Regulatory Affairs Coordinator

  • Specialty:

    Engineering
  • Title:

    Regulatory Affairs Coordinator
    • City:

      Plymouth
    • State:

      MN
    • Zip Code:

      55442
  • Start date:

    07-19-2019
  • Status:

    Closed
  • Assignment Type:

    Contract
  • Job Id:

    50097

Description

The DAVIS Companies is supporting a global leader in the medical device industry by identifying a Regulatory Affairs Coordinator. This is a tremendous opportunity to build a career that impacts the lives on a daily basis of its customers. 

Responsibilities of Regulatory Affairs Coordinator:

  • Technical support for regulatory agency submissions
  • Complete Registrations and Listings and ensure business unit sites and listings remain active and accurate on FDA database and other geographies requiring registrations
  • Process Certificates for Foreign Governments and of Free Sale
  • Document management for the department
  • Assistance in CAPA administration, data collection and metrics, payment of Regulatory filing and registration fees
  • Assist in preparation of submissions (e.g. letters, submissions packages, Acrobat linking, mailing)
  • Provide regulatory support for all product-specific activities related to gaining and maintaining market approval
  • Interface and support Team Members of the Regulatory Affairs and Quality Assurance staff.
  • Complete administrative duties including but not limited to: presentations, scheduling of on- and 0ff-site meetings including webcasts, department meetings and meetings with and visits to Regulators.

Requirements of Regulatory Affairs Coordinator:

  • Undergraduate university studies that normally last four years
  • Specific experience with implantable Medical Devices is recommended
  • Persistent and engaged; a good communicator
  • Resourcefulness; skills necessary to solve ongoing issues

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