Product Center Manager
Core
Manage product life cycle and enable project execution for new and mature medical devices across global markets, ensuring regulatory compliance and quality standards.
Role type
Senior Product Center Manager (Regulatory & Quality)
Builds
Medical device products and services (including dialysis therapies) compliant with global regulations
Domain
Medical Devices / Healthcare / Regulatory Affairs
Required skills
Project Management, Regulatory Affairs, Quality Assurance, Risk Management, ISO13485, ISO14971, MDR 2017/745, GMP, Technical/Engineering background
Preferred skills
Dialysis and related therapies knowledge, Medical device development/manufacture
Technologies
ISO13485, ISO14971, MDD 93/42/EEC, MDR 2017/745
Responsibilities
Manage product life cycle across global markets, Establish interfaces for global market access, Oversee capacity and competence management, Identify and communicate quality project risks, Monitor and report quality performance KPIs, Ensure regulatory intelligence is translated into processes, Foster continuous improvement culture
Seniority
Senior, hands-on IC