Quality & Regulatory Manager ANZ

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

Benefits offered by this job

Global leader in hearing healthcare

Influence across ANZ business

Exposure to regional and global teams

Collaborative culture

Professional development opportunities

Job summary

Sonova ANZ is seeking an experienced Quality & Regulatory Manager ANZ to lead our local quality management system and regulatory compliance across Australia and New Zealand. You will partner with stakeholders to drive continuous improvement, ensure audit readiness, and uphold high quality across products and processes.

Join a global leader in hearing healthcare, influencing regional quality strategies and collaborating with regional/global teams to deliver patient‑focused outcomes.

Qualifications

• Degree in Engineering, Manufacturing, or related field is required.
• Experience in Quality Management, Regulatory Affairs, Medical Devices, or regulated industry.
• Experience in GMP environments and audit processes.
• Strong QMS knowledge and audit capability; expertise in quality improvements.

Responsibilities

• Lead and maintain local QMS aligning with global requirements.
• Drive compliance with ISO 13485, ISO 9001, MDSAP and related standards.
• Manage QA operations, monitor processes and improvement opportunities.
• Oversee product release and qualification activities for compliance.
• Lead customer complaint investigations and corrective actions.
• Analyze quality trends and implement preventative actions.
• Collaborate with procurement and supplier quality teams.
• Serve as main contact for regulatory authorities and auditors.
• Plan and lead internal and external audits, ensuring readiness.
• Provide quality reporting and recommendations to leadership.
• Support quality/process improvement initiatives with analytics.

Skills

Quality management

Regulatory affairs

GMP experience

Auditing

Stakeholder management

Problem solving

Education

Degree in Engineering/Manufacturing or related

Job description

Select how often (in days) to receive an alert:

At Sonova, we envision a world where everyone can enjoy the delight of hearing. This vision inspires us and fuels our commitment to developing innovative solutions that improve hearing health and human connection - from personal audio devices and wireless communication systems to hearing aids and cochlear implants. We're dedicated to providing outstanding customer experiences through our global audiological care services, ensuring that everyone has the opportunity to engage fully with the world around them.

Here you’ll find a diverse range of opportunities that span both consumer and medical solutions and the freedom to shape your career while making an impact on the lives of others. Join us in our mission to create a more connected world, where every voice is heard and every story matters.

Baulkham Hills, Australia

Quality & Regulatory Manager ANZ

Quality & Regulatory Manager ANZ

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.

Sonova is an equal opportunity employer.

We team up. We grow talent. We collaborate with people of diverse backgrounds to win with the best team in the market place. We guarantee every person equal treatment in regard to employment and opportunity for employment, regardless of a candidate’s ethnic or national origin, religion, sexual orientation or marital status, gender, genetic identity, age, disability or any other legally protected status.