Ra/qa Specialist

6 months 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.

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