Provide technical direction for EU-DAMED implementation/maintenance; oversee UDI/mechanical data.
Requirements: Bachelors (or foreign equiv. deg.) in Mech Eng, Ind. Eng or rel. + 5 yrs of prog. exp. in EU MDR Regulatory Compliance, EUDAMED Submissions, UDI/device/actor registrations, technical doc. req./SSCP Lifecycle, verification/validation, risk management, engineering change controls, ISO 13485, 14971, 15223 compliance, Windchill PLM for document control/change management. Travel to various unanticipated domestic US client sites.
Application Instructions: Mail resume to: NovintiX Inc. 801 Springdale Drive, Suite 100-X, Exton, PA 19341.
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