Project Manager

• Coordinate and monitor the full certification cycle for medical devices under SGS NB 1639
• Act as the local representative for SGS Notified Body (NB) 1639 for the Medical Device Technical Liaison Office (MDTLO)
• Maintain an overview of ongoing certification processes and customer contract history
• Prepare and monitor the Certification Project Plan (IVDR only)
• Review and monitor Incident Notifications submitted by customers
• Track and report MDTLO KPIs and Delivering Office (DO) relationships (monthly reports)
• Support Quality or Regulatory teams with the investigation and resolution of complaints and non-conformities
• Generate and review weekly CertIQ reports to track Technical Documentation Assessment progress

Medical Devices Project Manager

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