**Your role:**
+ Leading cross‑functional change initiatives end‑to‑end, developing business cases, coordinating R&D, Quality, Regulatory, and Manufacturing through early design and V&V phases, and driving stakeholder engagement to deliver projects on time, within scope, and to quality expectations.
+ Overseeing change documentation and traceability in accordance with the Quality Management System (QMS), ensuring all required documents are created, maintained, and linked appropriately, and that products continue to meet applicable regulatory and industry standards.
+ Serving as the technical point of contact for internal and external audits across assigned product families, supporting audit preparation, execution, and follow‑up activities.
+ Acting as the technical interface for regulatory activities, including support of EU MDR submissions, China registrations, and other global regulatory requirements as applicable.
+ Providing technical leadership for product support a...