Job Details

  • Title: Regulatory MDR Specialist
  • Code: RCI-5686
  • Location: Minneapolis Minnesota (MN) 55442
  • Posted Date: 10/08/2020
  • Duration: 12 Months
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  Job Description

Manager is open for 100% Remote / work from home candidates as well

Description

  • Help cross-functional team assess gaps, develop and execute to plans for remediation
  • Regulatory MDR specialist to help facilitate remediation
  • Complete MDR-compliant STEDs, DoCs, etc.
  • Review/approve relevant DHF documentation, including risk analyses, test protocols and reports, clinical evaluation reports, postmarket surveillance plans, etc.
Relevant experience:
  • Things to look for on resume: - Clear and concise description of previous experience and relevant information; extraneous language is not preferred
  • 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
  • Simple, easy to follow formatting and presentation
Responsibilities
  • 5+ years of EU regulatory experience, but EU MDR experience might only be 1 or 2 of those. Specific MDD to MDR transition/remediation experience is a bonus.
  • Bachelor’s degree - Typically a scientific/technical background, but I’m flexible on this based on work experience. a. organized, good communicator (written and verbal), self motivated and directed, team player, understanding of technical files, understanding of MDR regulations and interpretations, written submissions to EU notified bodies before, experience working with cross-functional teams is very important