Location: Plymouth, MN
Duration: 6+ months

Position Responsibilities

Regulatory MDR specialist to help facilitate remediation for Class I devices – Complete MDR-compliant STEDs, DoCs, etc.

  • Help cross-functional team assess gaps, develop and execute to plans for remediation
  • Review/approve relevant DHF documentation, including risk analyses, test protocols and reports, clinical evaluation reports, postmarket surveillance plans, etc.

Basic Qualifications

  • BA or BS degree
  • Must have: Significant experience with EU submissions, particularly for new design examinations and significant changes since the release of MEDDEV 2.7.1, rev 4 (June 2016)
  • Previous experience working on development/implementation of MDR compliant procedures and documentation is desired

 

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