Quality & Regulatory Manager ANZ

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

Drive Quality Excellence. Protect Compliance. Make a Real Impact.

At Sonova, we're passionate about creating innovative hearing care solutions that help people reconnect with the moments that matter most. As a global leader in hearing healthcare, we're committed to improving lives through cutting-edge technology, world-class quality standards, and a customer-first mindset.

We're looking for an experienced Quality & Regulatory Manager ANZ to join our team and play a critical role in ensuring our products, processes, and quality systems meet the highest regulatory and compliance standards across Australia and New Zealand.

Why This Role Matters

In this highly visible role, you'll be the local expert and trusted advisor for quality and regulatory compliance, ensuring our Quality Management System remains robust, audit-ready, and aligned with global standards. You'll partner with stakeholders across the business to drive continuous improvement, enhance product quality, and maintain compliance throughout the product lifecycle.

This is an opportunity to combine strategic thinking with hands-on operational leadership, influencing quality outcomes that directly impact customers and patients across ANZ.

What You'll Be Doing

As the ANZ Quality & Regulatory Manager, you will:

• Lead and maintain the local Quality Management System (QMS), ensuring alignment with global requirements and continual improvement initiatives.
• Drive compliance with ISO 13485, ISO 9001, MDSAP and other applicable quality and regulatory standards.
• Manage quality assurance operations, monitoring processes and identifying opportunities for improvement.
• Oversee product release and qualification activities, ensuring quality and regulatory requirements are consistently met.
• Lead customer complaint investigations, corrective actions, and continuous improvement activities.
• Analyse quality trends and product performance data to identify risks and implement preventative actions.
• Partner with procurement, supplier quality, and operational teams to ensure supplier quality expectations are achieved.
• Serve as the key contact for regulatory authorities, certification bodies, and auditors.
• Plan, coordinate and lead internal and external audits, ensuring the organisation remains inspection-ready.
• Provide quality reporting, insights and recommendations to local leadership and regional quality teams.
• Support ongoing product quality and process improvement initiatives using analytical and statistical tools.

What You'll Bring

We're looking for a quality professional who thrives in a regulated environment and enjoys driving meaningful improvements.

• Degree qualification in Engineering, Manufacturing, or a related discipline.
• Significant experience within Quality Management, Quality Assurance, Regulatory Affairs, Medical Devices, Healthcare, or another highly regulated industry.
• Experience working within GMP and/or medical device environments.
• Strong knowledge of Quality Management Systems and audit processes.
• Proven experience managing customer complaints, corrective actions, risk management, and compliance activities.
• Excellent analytical, problem-solving, and stakeholder management skills.
• A proactive mindset with the ability to influence and drive change across the business.

Highly Regarded

• Experience with medical device regulations and standards including ISO 13485, ISO 9001, MDR, MDSAP, and FDA quality requirements.
• Experience in data analytics, statistical process control, or product quality improvement initiatives.

What Success Looks Like

You'll be someone who:

• Puts customers at the centre of decision-making.
• Thinks critically and solves complex problems.
• Plans effectively and delivers results.
• Builds trusted relationships across teams.
• Maintains exceptional attention to detail while balancing competing priorities.
• Takes ownership and acts with urgency when it matters most.

What We Offer

• The opportunity to work for a global leader in hearing healthcare and medical technology.
• A role with real influence across the ANZ business.
• Exposure to regional and global quality and regulatory teams.
• A collaborative and purpose-driven culture.
• Ongoing professional development and career growth opportunities.

Ready to make a difference?

If you're passionate about quality, compliance, continuous improvement, and making a positive impact on people's lives, we'd love to hear from you.