Project Manager - Medical Devices MDR (m/f/d)
Core
Lead cross-functional teams to deliver Medical Device Regulation (MDR) project outcomes for minimally invasive surgery devices, ensuring timely completion of technical documentation and submission readiness.
Role type
Senior Project Manager (Regulatory/Technical)
Builds
MDR-compliant technical documentation and regulatory submissions for medical devices
Domain
Medical Devices / Minimally Invasive Surgery / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
End-to-end project delivery, cross-functional leadership, risk management, stakeholder communication, document-heavy deliverable coordination, project management methodologies (Agile/Waterfall/PMP/Kaizen), process improvement
Preferred skills
SAP, Arena PLM knowledge
Technologies
SAP, Arena PLM
Responsibilities
Own end-to-end delivery for MDR projects ensuring portfolio alignment on scope, schedule, and dependencies; Coordinate responses and execution for customer MDR requests including impact assessment and tracking; Build and maintain integrated project plans with milestones and risk actions; Identify, assess, and mitigate project risks and resource constraints; Drive cross-functional collaboration across engineering, supply chain, and regulatory teams; Identify process improvement opportunities and coach teams on operational excellence tools; Track MDR documentation delivery and readiness reporting; Execute change procedures to monitor dependencies on MDR activities.
Seniority
Senior, hands-on IC