Ra/qa Specialist

1 week ago

Sydney, Australia Zimmer Biomet Full time

-Requisition Number
APAC05237
Employment Type
Full-time
Location
Sydney, New South Wales

**Job Summary**:

- At Zimmer Biomet ANZ, we are about transforming orthopaedics, and we believe in the need for Surgeons and Patients to have access to the combination of cutting edge technology and implants to give patients the best opportunity to improve their quality of life.We have a newly created contract role to support our QA/ QR team on a time critical project. Contracted for 2 years you will be responsible for managing all facets of regulatory support to all Zimmer Biomet segments products. This includes developing regulatory submissions, managing departmental projects, creating and reviewing labelling, providing guidance and consultation for regulations and interacting with government authorities in Australia and New Zealand
- As a regulatory affairs specialist your role involves working closely with regional and manufacturer teams to drive faster product registration cycles through Speed to Market initiatives. You will define and implement approval strategies, manage product submissions and approvals for EU MDR, TGA, and Medsafe, and ensure timely market release. Additionally, you'll maintain submission and approval databases, oversee compliance with SOPs, execute regulatory operations, and leverage relationships with authorities and industry groups to influence medical device regulations. You'll also contribute to regulatory compliance, including reporting adverse events and facilitating timely closures.Sounds like you? This is what we are looking for:

- Must have End-to-End TGA submission for Higher Class including but not limited to TGA conformity Assessment - Class 3
- Degree or tertiary qualifications in life sciences or Engineering or similar
- Strong end to End TGA conformity Assessment experiences
- Minimum 3 years experience in Australian and New Zealand Regulatory requirements for medical devices
- Problem solving skills applicable to complex regulatory, quality and safety issues
- Excellent communication, planning and organizational skills
- Ability to work well in cross functional team environment
- Strong attention to detail
- Ability to work well under pressure
- Excellent computer skills in Microsoft Word, Excel, SharePoint, Power Point, Project
- Demonstrated database proficiency
- On offer is a competitive salary and an exciting opportunity to be a part of a Dynamic Company
- About Us
- As the leading innovator in musculoskeletal healthcare, our cutting edge robotics technology, interactive digital platforms, and comprehensive portfolio of products for joint reconstruction, bone and skeletal repair, sports and spinal injuries, help restore mobility, alleviate pain, and improve the quality of life for patients. Collaborating with top healthcare professionals around the globe to speed the pace of innovation, and expand the possibilities for successful treatment outcomes, Zimmer Biomet remains committed to our promise to look beyond what’s possible now, and discover what’s possible next.

  • RA/QA Director

    5 days ago

    Sydney, New South Wales, Australia Aegros Full time $120,000 - $180,000 per year

    Company DescriptionAegros is committed to ensuring access to life-saving therapeutic plasma drugs as a human right. Utilizing our Australian-invented Haemafrac electroseparation process, we innovate to put patients first. Based in Macquarie Park, Sydney, our TGA GMP-approved plasma fractionation plant manufactures a hyperimmune immunoglobulin product against...

  • Head of Field Service Engineering, Applications and QA/RA

    2 weeks ago

    Sydney, New South Wales, Australia Tardis Group Full time $120,000 - $150,000 per year

    Ready to redefine customer experience in the clinical diagnostics space?We're looking for an experienced and visionary leader to take on a pivotal role in driving Customer Care excellence, quality, and compliance across Australia. If you're passionate about delivering service that sets new industry benchmarks and want to play a key role in transforming how...

  • Senior Quality Assurance Specialist

    3 days ago

    Sydney, New South Wales, Australia GN Group Full time $90,000 - $120,000 per year

    At GN Hearing, we're driven by a simple but powerful purpose: to make life sound better. As one of the world's leading innovators in hearing solutions, we combine cutting-edge technology, quality, and care to transform lives every day.We're now looking for a Senior Quality Assurance Specialist to join our high-performing Operations team in Sydney. This role...

  • ▷ [3 Days Left] Senior Quality Assurance Specialist

    3 weeks ago

    Council of the City of Sydney, Australia GN Group Full time

    Senior Quality Assurance Specialist page is loaded## Senior Quality Assurance Specialistlocations: Sydneytime type: Full timeposted on: Posted Todaytime left to apply: End Date: November 10, 2025 (30 days left to apply)job requisition id: R26809At GN Hearing, we’re driven by a simple but powerful purpose: to make life sound better. As one of the...

  • Senior QA Engineer

    2 weeks ago

    Sydney, New South Wales, Australia Resmed Full time $120,000 - $180,000 per year

    The primary role of Quality Assurance function is to ensure that management systems are established to enable business compliance, multiple regulatory frameworks and to support the design, development and manufacture of products which meet our customer's quality requirements. Key deliverables include creating and building relationships with medical device...

  • Quality Assurance

    2 weeks ago

    Sydney, New South Wales, Australia GN Group Full time $90,000 - $120,000 per year

    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 youWe're on the lookout for aQuality Assurance & Regulatory Affairs Associateto support and elevate our ANZ...

  • Digital QA Specialist

    2 weeks ago

    Sydney Inner Suburbs, Australia Suncorp Group Full time

    **Digital QA Specialist** - **Location: Sydney, Melbourne, or Brisbane**: - **12-Month Fixed Term Contract** Are you passionate about delivering high-quality digital experiences? Join our team as a **Digital QA Specialist**and play a key role in ensuring our digital initiatives meet the highest standards. **About the Role** As part of the Digital...

  • QA Analyst Kpmg Origins

    7 days ago

    Sydney, Australia KPMG Full time

    **KPMG Origins** is a SaaS startup (a KPMG venture) that streamlines interactions between organisations, industries, and borders to enable supply chain ecosystems to thrive via trustworthy data. Our mission is to address the global pressing problems of today, such as cost of living, food insecurity, sustainability, human rights, consumer transparency and...

  • QA Analyst Kpmg Origins

    7 days ago

    Sydney, Australia KPMG Australia Full time

    **Job Description**: **KPMG Origins** is a SaaS startup (a KPMG venture) that streamlines interactions between organisations, industries, and borders to enable supply chain ecosystems to thrive via trustworthy data. Our mission is to address the global pressing problems of today, such as cost of living, food insecurity, sustainability, human rights,...

  • Product Quality Assurance

    5 days ago

    Sydney, New South Wales, Australia Resmed Full time $80,000 - $120,000 per year

    The Product Quality function partners with Engineering and cross-functional teams to enable the efficient and compliant release of a diverse range of products.This role focuses on Delivery Excellence —driving the velocity of product releases in line with established strategies, while also contributing expertise to shape new strategies and improve design...