Quality & Regulatory Manager ANZ
Core
Local expert and trusted advisor for quality and regulatory compliance, ensuring the Quality Management System remains robust, audit-ready, and aligned with global standards across Australia and New Zealand.
Role type
Senior IC Quality & Regulatory Manager
Builds
Hearing care solutions (hearing devices)
Domain
Medical Devices / Healthcare / Regulated Industry
Required skills
Quality Management Systems (QMS), ISO 13485, ISO 9001, MDSAP, GMP, audit management, customer complaint investigations, corrective actions, risk management, supplier quality, regulatory liaison, data analysis
Preferred skills
Lead Auditor, LEAN Six Sigma, statistical process control, FDA quality requirements, MDR
Technologies
ISO 13485, ISO 9001, MDSAP, GMP, MDR, FDA
Responsibilities
Lead and maintain the local Quality Management System (QMS), Drive compliance with ISO 13485, ISO 9001, MDSAP, Manage quality assurance operations and supplier quality, Oversee product release and qualification, Lead customer complaint investigations and corrective actions, Plan and lead internal and external audits, Serve as key contact for regulatory authorities and auditors, Provide quality reporting and insights to leadership
Seniority
Senior, hands-on IC