ANZ Quality & Regulatory Manager: Drive Compliance

Sonova; Sydney; On-site; AUD 150,000 - 190,000; Full time

Job summary

Sonova in Sydney, Australia, is seeking an experienced Quality & Regulatory Manager ANZ to ensure regulatory compliance and robust QMS across Australia and New Zealand.

You will lead audit readiness, drive continuous improvement, manage supplier quality, and partner with stakeholders to maintain high product quality and patient safety.

This role combines strategic leadership with hands-on execution in a regulated environment, offering influence across ANZ and global quality teams.

Qualifications

• Degree in Engineering, Manufacturing or related discipline.
• Experience in Quality Management, Quality Assurance, Regulatory Affairs, Medical Devices or regulated industries.
• GMP/medical device environment experience.
• Strong knowledge of QMS and audit processes.
• Experience handling customer complaints, CAPAs, risk management and compliance.
• Analytical, problem-solving and stakeholder management skills.
• Proactive mindset with ability to influence change.

Responsibilities

• Lead and maintain local QMS aligned with global requirements and continual improvement.
• Drive compliance with ISO 13485, ISO 9001, MDSAP and applicable standards.
• Manage QA operations, monitor processes and identify improvement opportunities.
• Oversee product release and qualification activities ensuring regulatory compliance.
• Lead customer complaint investigations and corrective actions.
• Analyze quality trends and product performance to identify risks and preventative actions.
• Collaborate with procurement, supplier quality and operations to meet supplier quality expectations.
• Act as key contact for regulatory authorities, cert bodies and auditors.
• Plan, coordinate and lead internal and external audits.
• Provide quality reporting and insights to leadership and regional teams.

Job description

Sonova in Sydney, Australia, is seeking an experienced Quality & Regulatory Manager ANZ to ensure regulatory compliance and robust QMS across Australia and New Zealand.

You will lead audit readiness, drive continuous improvement, manage supplier quality, and partner with stakeholders to maintain high product quality and patient safety.

This role combines strategic leadership with hands-on execution in a regulated environment, offering influence across ANZ and global quality teams.