Manager, Electrophysiology & Neurovascular (EP/NV) Commercial Quality, ANZ
Core
Lead Commercial Quality for Electrophysiology and Neurovascular products and services across Australia and New Zealand, ensuring regulatory compliance and patient safety.
Role type
Manager, Commercial Quality (People Leader)
Builds
Compliant, high-quality products and services for EP/NV businesses
Domain
Medical Devices / MedTech
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management Systems, CAPA, risk management, post-market surveillance, audit management, supplier quality management, regulatory compliance, people leadership, budget management
Preferred skills
Matrix organization experience, shared-service quality models
Technologies
ISO 13485, MDSAP, Australian TGA regulations, New Zealand Medsafe requirements
Responsibilities
Lead Commercial Quality activities and execute quality strategies; Ensure QMS compliance and drive CAPA effectiveness; Oversee post-market surveillance, complaints, and recalls; Partner with business leaders and supply chain on quality oversight; Lead, coach, and develop the Commercial Quality team.
Seniority
Manager, hands-on IC with team leadership