Quality Assurance and Regulatory Associate
1 week ago
Our client is a renowned global manufacturer of products used in testing for multiple infectious diseases. Due to growth, their team is expanding and they are seeking a Quality Assurance and Regulatory Associate to join the team in Sydney. This is an exciting opportunity to support both functions and learn from an experienced head of QA/RA. Our client strives to create an inclusive culture in which difference is recognised and valued.
About the Role:The role offers a unique opportunity to work for an IVD manufacturer/sponsor, with responsibilities in both quality and regulatory areas. The successful candidate will be involved in enhancing the quality management system and will also contribute to compiling dossiers and technical files for IVDR, WHO, and TGA submissions.
Key Responsibilities:- Compile data on QMS processes and participate in the generation of CAPAs, NCRs, Document Control and Complaint handling.
- Assist with technical writing and SOP preparation.
- Support post-audit CAPA investigations with the R&D team.
- Support regulatory file maintenance projects.
- Research emerging regulatory/technical areas related to department projects.
- Create PowerPoint training presentations on MQS/new regulations.
- Build relationships with key stakeholders cross-functionally.
We are seeking a highly motivated and experienced Quality Assurance and Regulatory Associate to join our team. The ideal candidate will have a medical science, biochemistry or biomedical engineering background and relevant QARA experience of 2-3 years in a manufacturing Australian sponsor setting. Additionally, you should be an enthusiastic, collaborative team player who is keen to learn.
- Practical knowledge and understanding of ISO13485.
- Proven technical writing skills.
- Clear communication and interpersonal skills.
- High Attention to detail.
- Experience working with QMS and MS Office - word, PowerPoint, excel.
- Team player with a 'Can do' attitude.
We offer a dynamic and supportive work environment, with opportunities for professional growth and development. Our team is passionate about delivering high-quality results and making a positive impact in the industry.
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Sydney, New South Wales, Australia KE Select Full timeAbout the Company:Our client is a prominent global manufacturer recognized for its innovative products utilized in the testing of various infectious diseases. As the organization expands, they are seeking to recruit a Quality Assurance and Regulatory Affairs Associate to enhance their team in Sydney. This position presents an exciting opportunity to engage...
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Sydney, New South Wales, Australia KE Select Full timeAbout the Company:Our client is a leading global manufacturer recognized for its innovative products utilized in the diagnosis of various infectious diseases. As a result of their ongoing expansion, they are seeking to appoint a Quality Assurance and Regulatory Affairs Associate in Sydney. This role presents an exciting opportunity to engage with both...
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Sydney, New South Wales, Australia KE Select Full timeAbout the Company:Our client is a prominent global manufacturer recognized for its innovative products utilized in the testing of various infectious diseases. As the organization continues to expand, they are seeking to recruit a Quality Assurance and Regulatory Affairs Associate to enhance their operations in Sydney. This role presents an exciting...
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