Product Center Manager Active Medical Devices & Digital Products (m/f/d)
Core
Managing the product lifecycle for active medical devices and digital products to ensure safe, efficient, and compliant delivery across global markets.
Role type
Product Center Manager (Medical Devices & Digital Products)
Builds
Active medical devices, medical device systems, and digital health solutions for kidney care patients.
Domain
Healthcare / Medical Devices / Digital Health
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Medical device regulations (NMPA, MDD, MDR, MDSAP, FDA), Quality management standards (ISO 13485, ISO 14971, ICH Q10, EU GMP), Risk management, Project management, Digital medical devices (SaMD), Product lifecycle management, Global market access, Stakeholder coordination, Performance monitoring (KPIs), Document management systems.
Preferred skills
Medical device development processes, Supplier quality handling, Production transfer, Dialysis and related therapies application knowledge.
Technologies
Global document management systems, Regulatory intelligence platforms.
Responsibilities
Enable project execution and manage product lifecycle across global markets; Establish interfaces with Business Units and cross-functional teams for market access; Oversee capacity management and prioritization of Product Center activities; Identify and communicate quality-related project risks; Translate regulatory intelligence into internal processes; Collaborate to ensure regulatory compliance and patient outcomes; Develop and monitor performance against KPIs; Monitor and report on quality performance for the product portfolio; Support creation of harmonized document management structures; Act as quality representative in cross-functional teams; Support risk evaluation for severe product risks in post-market surveillance.
Seniority
Senior, hands-on IC