Senior Project Manager, Post Market Surveillance, EMEA

The Senior Project Manager, Post Market Surveillance, EMEA leads systems-related project management within the RAQA function to ensure compliance with regulatory requirements and safeguard patient safety. The role focuses on implementing and improving PMS systems, training teams, managing scope/risk/change control, and supporting EMEA RAQA teams and audit readiness.

• Lead project management for PMS-related systems implementation and improvement
• Assemble teams, assign responsibilities, identify resources, and develop schedules for system deployment
• Define and communicate scope, benefits, requirements, and deliverables for the team and business
• Manage system changes across scope, timing, and costs using verification techniques
• Lead risk identification/assessment/monitoring/closure and support BSI audit program plus EMEA SharePoint updates

This role is centered on digital systems enablement for PMS/Vigilance, including systems implementation and improvement using EUDAMED DATA BASE, MORE DATA BASE, TW, and Power BI. It also includes ongoing systems management, performance measurement, SharePoint updates, and audit support for the BSI audit program.

The ideal candidate is a senior project manager for Post Market Surveillance (PMS)/Vigilance under the RAQA function, with strong familiarity with PMS frameworks, procedures, and legislative/regulatory requirements in an EMEA distribution context. They have led systems implementation and improvement using tools like EUDAMED DATA BASE and Power BI, managed scope/risk/change control, trained teams to use deployed systems, and supported audits such as the BSI audit program.