Location: Plymouth, MN
Duration: 6+ months
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.
- 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