Product Center Manager
Core
Manage product lifecycle and ensure regulatory compliance for medical devices and digital health products across global markets.
Role type
Senior Product Center Manager (Regulatory & Quality)
Builds
Safe, efficient, and compliant medical device products and digital services
Domain
Medical Devices / Healthcare / Regulatory Affairs
Required skills
Medical device regulations (MDR, MDD), Quality Management Systems (ISO13485, GMP), Risk Management (ISO14971), Project Management, Global market access strategy, Regulatory intelligence translation, KPI monitoring, Cross-functional collaboration
Preferred skills
Dialysis and related therapies domain knowledge, Experience with external body auditing
Technologies
ISO13485, ISO14971, EU MDR, MDD 93/42/EEC, IFDA 21 CDR §820.250
Responsibilities
Manage product lifecycle across global markets, Establish interfaces for fast global market access, Oversee capacity and competence management, Request SQR resources per roadmap, Trigger functional involvement for new product development, Identify and communicate quality risks, Develop and monitor performance KPIs, Translate regulatory intelligence into processes, Foster continuous improvement culture, Monitor quality performance across product portfolio
Seniority
Senior, hands-on IC