Do you thrive in a fast-paced environment where quality and regulatory compliance are key to success? Are you an ISO 13485 expert with a keen eye for risk and continuous improvement? If so, GN Hearing Australia has the perfect opportunity for you! We're on the lookout for a Quality Assurance & Regulatory Affairs Associate to support and elevate our ANZ operations. You'll play a crucial role in ensuring compliance with regulatory standards and GN's global quality management system - while helping improve lives through advanced hearing solutions. As our QA/RA Associate, you'll: - Lead day-to-day QA and RA functions for Australia, New Zealand, and affiliates. - Support compliance with ISO13485 and local regulatory standards. - Act as the local Subject Matter Expert for quality processes and risk assessments. - Conduct internal audits and manage CAPAs, NCs, and quality records. - Drive validation activities for custom-manufactured products at our Sydney facility. - Collaborate with internal teams and corporate stakeholders across the globe. - Train and support teams on quality and 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. We're looking for someone who: - Has a solid understanding of ISO 13485 and quality systems. - Knows their way around internal auditing, CAPA, and validation processes. - Is confident, detail-oriented, and self-motivated. - Communicates effectively with stakeholders at all levels. - Has 3 years' experience in a QA/RA role, ideally in medical devices. - Is a natural problem-solver and thrives in a process-driven environment. GN brings people closer through our leading intelligent hearing, audio, video, and gaming solutions. Inspired by people and driven by innovation, we deliver technology that enhance the senses of hearing and sight. We help people with hearing loss overcome real-life challenges, improve communication and collaboration for businesses, and provide great experiences for audio and gaming enthusiasts. GN was founded more than 150 years ago with a vision to connect the world. Today, inspired by our strong heritage, GN touches more lives than ever with the broadest portfolio of products and services in our history - fostering a sense of community, openness, and understanding. By listening to customers and combining our unique expertise in the human ear, audio, video, and speech, wireless technologies, software, and miniaturization, we transform what it takes to bring people closer to what is important to them. The GN-owned brands that are responsible for bringing these technologies to life: - Medical grade hearing technology: ReSound (https://www.resound.com/en) , Beltone (https://www.beltone.com/en) , Interton (https://www.interton.com/en) , Jabra (https://www.jabra.com/hearing) - Professional collaboration: Jabra (https://www.jabra.com/) , BlueParrott (https://www.emea.blueparrott.com/) , FalCom (https://falcom.gn.com/) - Gaming, calls and media: SteelSeries (https://steelseries.com/) , Jabra (https://www.jabra.com/) Founded in 1869, the GN Group employs 7,000 people and is listed on Nasdaq Copenhagen (GN.CO). GN's solutions are sold in around 100 countries across the world. If you would like to learn more about us, visit our homepage gn.com or click on our different brands. You can also connect with us on LinkedIn (https://www.linkedin.com/company/gn-store-nord/) , Facebook (https://www.facebook.com/gnstorenord/) and Twitter (https://twitter.com/gnstorenord) . We are a Equal Opportunity Employer that values a diverse and inclusive workforce. We do not discriminate on the basis of race, color, national origin, religion, age, gender identity, sexual orientation, marital status, disability, genetic information, veteran status, or any other basis prohibited by federal, state, or local law. Women, minorities, veterans, LGBTQIA individuals, and persons with disabilities are encouraged to apply. Come join our team!
