Overview: Full-time fixed term contract for 12 months with possible future options for ongoing appointment. Salary depending on experience, plus superannuation

Effective Date:

Immediate appointment

The role:

This exciting chance will enable an experienced Technical Writer for scientific documentation for in vitro diagnostics to join the ZiP Diagnostics team. You will contribute to the design, development and production of new point-of-care molecular diagnostic tests.
You will be part of a diverse team of skilled R&D; scientists, production scientists, and engineers creating innovative point-of-care tests for human, animal and environmental applications. You will be based at our facility in the inner-Melbourne suburb of Collingwood.

Your responsibilities:

- Create and review plans, procedures and reports for technical descriptions, product specifications, risk analysis, research & development, manufacturing, quality control, verification and validation, labels/ packaging, analytical and clinical performance, user manuals, and instructions of use.
- Familiarity with Quality Management System documentation requirements, change orders, regulatory submissions and reporting.




- Provide reports to management and supervisors on the status of documentation and technical writing activities.
- Attendance and participation in research meetings.
- Engage with R&D;, production, QA/QC, engineering, clinical, regulatory teams, sales/ marketing, business development and senior management teams.
- Tertiary level education in biomedical science.
- Previous work experience in the biomedical sector.
- Excellent writing and communication skills in biomedicine, ideally diagnostics.
- Experience in documentation of systems science and/ or engineering.
- Knowledge and practical experience in analytical and clinical validation studies.
- Knowledge and practical experience in regulatory requirements for human and animal in vitro diagnostic tests.
- Knowledge and practical experience in the preparation of scientific and technical reports, grants, publications, and presentations.
- Experience with in vitro diagnostics.
- Previous experience working in industry, including manufacturing and QA/ QC.
- Experience working with ISO13485 or NATA Quality Management Systems.
- Experience with regulatory processes and documentation.

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📌 Technical writer (Scientific Documentation for in vitro diagnostics) (Williamstown)
🏢 Zip Diagnostics
📍 Williamstown