Job Details

  • Title: Regulatory Affairs Associate
  • Code: RCI-5668
  • Location: Saint Paul Minnesota (MN) 55117
  • Posted Date: 10/09/2020
  • Duration: 13 Months
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  Job Description

100% Remote/ Work from home

  • Bachelor’s degree with 3 yrs. of exp will work depending on the experience they have
  • Min of 5 yrs. of exp in regulatory
  • MED DEV to MDR gap assessment exp
  • EU regulatory exp is a must have
  • Med dev 2.7.1 exp is not a must have if they have strong regulatory experience
  • Specific EUMDR exp or  EU regulatory experience needed
  • If they have strong regulatory exp then high school will also work
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
  • Previous experience working on development/implementation of MDR compliant procedures and documentation is desired
  • Simple, easy to follow formatting and presentation