Zimmer Biomet

JOB DESCRIPTION What You Can ExpectHow You’ll Create ImpactWhat Makes You Stand OutYour BackgroundTravel ExpectationsAt 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 currently have a vacancy in our Sydney Head Office for a a Regulatory Affairs Associate. 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 a regulatory affairs associate 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 : MDR preparation and submission experiences for Orthopaedic Devices EU and TGA submission experience for Orthopaedic DevicesClass III ExperienceMinimum 3 years experience in regulatory requirements for medical devices Degree or tertiary qualifications in life sciences or Engineering or similar 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.