Quality Assurance and Regulatory Affairs Specialist

1 week ago


Sydney, New South Wales, Australia KE Select Full time

About 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 quality and regulatory functions while gaining insights from a seasoned leader in QA/RA. The organization is committed to fostering an inclusive environment where diversity is acknowledged and appreciated.

About the Role:

This position offers a distinctive chance to work within an IVD manufacturing environment, encompassing responsibilities across both quality and regulatory domains. The selected candidate will play a vital role in enhancing the quality management system and will also assist in the preparation of technical documentation and submissions for IVDR, WHO, and TGA.

Key Responsibilities:

  • Gather and analyze data related to QMS processes and contribute to the development of CAPAs, NCRs, Document Control, and Complaint management.
  • Assist in technical documentation and the creation of Standard Operating Procedures (SOPs).
  • Support post-audit CAPA investigations in collaboration with the R&D team.
  • Contribute to regulatory file maintenance initiatives.
  • Investigate emerging regulatory and technical trends pertinent to departmental projects.
  • Develop training presentations in PowerPoint regarding MQS and new regulatory requirements.
  • Establish and maintain relationships with key stakeholders across various functions.

This is an excellent opportunity for individuals to leverage their quality and regulatory expertise within the Diagnostics or Medical Device sector. Candidates should ideally possess a background in medical science, biochemistry, or biomedical engineering, along with 2-3 years of relevant QARA experience in a manufacturing context. Furthermore, we seek enthusiastic, collaborative team players eager to learn and grow.

About You:

  • Solid understanding of ISO13485 standards.
  • Demonstrated technical writing capabilities.
  • Effective communication and interpersonal skills.
  • Meticulous attention to detail.
  • Experience with QMS and proficiency in MS Office applications including Word, PowerPoint, and Excel.
  • A proactive team player with a positive attitude.

While flexibility is offered regarding office attendance, a minimum of three days in the office is required.

How to Apply:

If you believe this role aligns with your skills and experience, we encourage you to express your interest. We are currently in the process of short-listing candidates for this position.

KE Select is a premier Australian recruitment partner specializing in the Scientific and Medical sectors, serving numerous organizations within Life Sciences, Medical, Clinical, Hospital, and Healthcare fields. We focus on both Permanent and Temporary recruitment across Australia and New Zealand. For candidates seeking new opportunities or companies in need of industry-specific recruitment services, we invite you to explore our website for further information.



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