Regulatory Assurance/ Quality Assurance Associate

Regulatory Assurance & Quality Assurance (RA/QA) Associate
North Ryde, Sydney | Full Time

GN is a global leader in intelligent audio solutions, operating across the healthcare and technology industries with world-renowned brands including ReSound, Beltone, Jabra, SteelSeries and BlueParrott. For more than 150 years, we have been driven by a shared purpose — to make life sound better through the power of sound, innovation, and human connection.

At GN, we combine pioneering technology with deep expertise to create products that improve communication, hearing, and everyday experiences for millions of people worldwide. As our business continues to grow, we remain focused on delivering meaningful solutions across both existing and emerging markets.

About the Role

At GN Hearing, the leading hearing aid company in the Australian market, we believe in transforming lives through better hearing and exceptional customer experiences. We are looking for a motivated and detail-oriented professional to join our ANZ Quality team as a Regulatory Assurance & Quality Assurance (RA/QA) Associate.

This is an exciting opportunity to play a key role in supporting regulatory compliance and quality assurance activities across Australia, New Zealand, and affiliate markets. Working closely with both local and global stakeholders, you will help ensure our products and processes meet the highest regulatory and quality standards while contributing to meaningful outcomes for people living with hearing loss.

If you thrive in a collaborative environment, enjoy working with processes and compliance frameworks, and take pride in delivering high-quality outcomes, we would love to hear from you.

Key Responsibilities

As our RA/QA Associate, you’ll:

• Lead day-to-day RA functions for Australia, New Zealand, and affiliates.

• Act as the local Subject Matter Expert for Regulatory, MDR and Vigilance for ANZ.

• Manage regulatory compliance for Product Launches and Marketing Collateral for ANZ

• Support compliance with ISO13485 and local regulatory standards.

• Manage the ANZ Quality Management System

• Collaborate with internal teams and corporate stakeholders across the globe.

• Train and support teams on regulatory matters.

• Represent the business in local QA/RA meetings and interactions with TGA and other bodies.

• Be a key player in a high-performing, values-led QA/RA team.

Requirements

• Has a minimum of 2-3 years’ experience in a similar RA role, managing regulatory compliance, product submissions and MDR/vigilance reporting under Australian Regulations for Medical Devices.

• Solid experience of ISO 13485 and quality systems.

• Is confident, detail-oriented, self-motivated, and able to work autonomously.

• Communicates effectively with stakeholders at all levels.

• Is a natural problem-solver and thrives in a process-driven environment.

Benefits

• Flexible work arrangements after probation (currently 2 days per week from home)

• Generous discounts with hundreds of retailers

• Access to online well-being center

• Employee Assistance Program and regular wellbeing webinars

• Generous discounts on GN Hearing products

• Gift vouchers for birthdays, service anniversaries, and values-based awards

• Free annual flu vaccinations

• Weekly fresh fruit deliveries

• Convenient office location close to public transportation

If this sounds like the opportunity you've been waiting for, we'd love to hear from you! Please note that we can only consider applicants with full, unrestricted Australian work rights.  

GN Hearing Australia is an Equal Opportunity Employer and values diversity, equity and inclusion. We encourage applications from Aboriginal and Torres Strait Islander peoples and from people of diverse cultural backgrounds.

We are committed to a barrier-free recruitment process and workplace. If you require adjustments during the recruitment process, please let us know so we can support your participation.

GN Store Nord A/S has entered into a definitive agreement for the sale of GN’s Hearing business to Amplifon S.p.A. to create a global leader in audiology. For GN Group, this creates an opportunity to further expand our position in the large audio and video peripherals markets. Read more about the announcement here. 

Agencies: We prefer to fill this role directly. Should we require assistance, we will contact our preferred recruitment partners.