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Quality & Regulatory Manager
2 weeks ago
The Company
Our client is an Australian biotechnology company pioneering advanced diagnostics and novel technologies to enhance cancer detection and treatment. With a growing pipeline targeting solid tumours and a focus on developing new therapeutic approaches, the company continues to deliver promising results with the potential to improve patient outcomes.
The Opportunity
This role will lead quality initiatives, manage assigned projects, and promote a culture of regulatory readiness and improvement throughout the company and its teams:
- Provide strategic leadership for quality and regulatory affairs across the organization to achieve and maintain NATA accreditation for R&D and analytical laboratory operations.
- Oversee the company's Quality Management System in line with ISO, cGMP, and ICH Q10 standards across diagnostics, medical devices, and therapeutics.
- Ensure compliance with ISO/IEC 17025, ISO 13485, ISO 15189, and liaise with regulatory bodies (TGA, FDA, EMA, NATA) for product registration and submissions.
- Facilitate internal/external audits, manage CAPA processes, document control, risk management, and change management activities.
- Prepare and review documentation for IND/NDA/clinical trials, including validation data and manufacturing records.
The Requirements
- Tertiary qualification in a relevant discipline of life sciences or medical technology.
- Proven success in achieving or maintaining accreditation or certification under at least one of the following standards: ISO 17025, ISO 13485, or ISO 15189.
- Hands-on experience implementing and maintaining Quality Management Systems (QMS) in compliance with ISO standards, particularly ISO 13485 and/or ISO 17025.
- Minimum of three years' experience in quality management within the biotechnology, diagnostics, medical device, or pharmaceutical sectors.
- Demonstrated engagement with regulatory authorities such as NATA, TGA, FDA, or EMA, including participation in site audits, addressing findings, and supporting product registration.
- Exceptional written and verbal communication skills, strong organizational capabilities, and meticulous attention to detail, as evidenced through CV and interview performance.
The Offer
As Quality & Regulatory Manager, you'll play a pivotal role in shaping the company's compliance and quality systems while contributing to the development of cutting-edge diagnostic technologies. This is a full-time, Melbourne-based opportunity offering a competitive salary package and, a flexible position title reflective of experience level, and potential access to bonus and incentives. To learn more about this exciting opportunity, please email any questions you have to , call , or visit to "Apply Now" with your current CV and cover letter addressed to Marilyn Jones and/or Mark Thomas.
