Regulatory Affairs & Quality Assurance Associate
Zimmer Biomet · Sydney, New South Wales ·
- Work mode
- Hybrid
- Category
- QA
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.
What You Can Expect
Help bring innovative medical technologies to patients across Australia and New Zealand. As a Regulatory Affairs & Quality Assurance Associate, you will support regulatory activities for an assigned portfolio of orthopaedic implants, surgical instruments and enabling technologies, including robotics and software.
This is a development-focused role with approximately 80% in Regulatory Affairs and 20% in Quality Assurance. Working alongside experienced colleagues, you will build practical expertise across submissions, product lifecycle activities, regulatory intelligence and post-market requirements while contributing to patient safety and timely product availability. You will collaborate with in-country stakeholders and regional and global teams.
How You'll Create Impact
- Support regulatory activities for an assigned ANZ portfolio of orthopaedic implants, surgical instruments, robotics and software-related products.
- Prepare and coordinate documentation for submissions, renewals and product changes, track milestones and flag issues or delays to the responsible senior colleague.
- Contribute information for registration plans and strategies; undertake defined tasks with guidance from the QA/RA Manager or Regulatory Affairs Specialist.
- Monitor regulatory updates and prepare initial impact summaries for review, helping track agreed actions.
- Support post-market activities, including complaint and adverse-event documentation, field safety action coordination and required reporting, under appropriate direction.
- Assist with review of labelling, promotional and digital materials for compliance with applicable requirements and internal policies.
- Maintain accurate submission schedules, approval records, regulatory trackers and change-notification information in relevant systems.
- Support assigned Quality Assurance activities, including audit preparation, evidence collation, supplier documentation and QMS procedure updates.
- Build effective working relationships with in-country stakeholders and regional and global colleagues, escalating complex questions and regulatory decisions as appropriate.
- Develop capability through hands-on exposure to the medical-device lifecycle, structured guidance and collaboration with experienced RAQA professionals.
What Makes You Stand Out
- Degree qualified in science, healthcare, engineering or a related discipline
- Curious and analytical, with the ability to interpret guidance, organise information and prepare clear summaries for review
- Some experience in Regulatory Affairs, Quality or another regulated healthcare or medical-device environment; 3 years’ relevant experience is preferred.
- Familiarity with Australian and New Zealand medical-device requirements is an advantage.
- Be able to work to tight deadlines and timelines
- High attention to detail
- Excellent communication; written, verbal and presentation
- Clear communication and relationship-building skills, with the ability to coordinate assigned tasks across local, regional and global teams
Travel Expectations
Up to 5%. Hybrid working arrangement; remote flexibility may be considered for a suitable candidate.