Job Details: Technical Documentation Specialist (Medical Devices & ISO 13485)Full details of the job. Australia Technical Documentation Specialist (Medical Devices & ISO 13485) VN421 Full-Time Production Quality The Technical Documentation Specialist is responsible for preparing and maintaining compliant medical device technical documentation, with clear evidence mapping and traceability across the product lifecycle. • Supports new and commercial products, including technical files for new and legacy devices. • Contributes to SDI Strategic Priorities and works safely in line with SDI's values of passion, accountability, respect, teamwork, and innovation. • Prepare, review and maintain technical file documentation for new and legacy medical devices, ensuring content is clear, complete, evidence-based and suitable for regulatory submission or audit review. • Ensure technical documentation demonstrates compliance with applicable requirements, including EU MDR Annex II/III, GSPRs, FDA 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP and relevant product standards. • Develop and maintain traceability matrices linking regulatory requirements, GSPRs, design inputs/outputs, risks and controls, verification/validation evidence, labelling, claims and post-market data. • Provide quality and regulatory input to submissions, technical documentation updates, design changes and product lifecycle activities. • Collaborate with R&D, Manufacturing, Quality, Regulatory and Marketing to embed compliance requirements in relevant processes and documentation. • Improve technical documentation templates, procedures and tools, including MDR evidence mapping and technical file traceability templates. • Support Quality activities and ensure work is performed in accordance with the QMS, ISO 13485, MDSAP, EU MDR and other applicable requirements. • Support risk management, design control and periodic standards review, including assessment of regulatory or standards changes that may impact products or technical documentation. • External - Equipment suppliers, laboratories, research organisations, consultants and regulators. • Internal - R&D, QA, QC, Regulatory Affairs, Manufacturing and Marketing. The position is located at Bayswater and Montrose Working hours: 38 hours per week Bachelor's Degree • Degree in a scientific, engineering or related discipline. • Experience in design control, risk management, verification/validation, document control and/or medical device technical documentation. • Experience preparing or maintaining EU MDR technical documentation, including Annex II/III and GSPR evidence alignment. • Practical understanding of EU MDR, ISO 13485, ISO 14971, MDSAP, FDA 21 CFR Part 820 and relevant IEC/ISO product standards. • Experience with traceability matrices is highly regarded. • 5+ years' experience in Regulatory Affairs, Quality Assurance or Research and Development is desirable. • Proficient in MS Word, Excel, MS Project and other relevant computer software. • Able to summarise complex technical and regulatory information clearly. • Strong understanding of medical device technical documentation, manufacturing processes and quality management systems. • Ability to structure technical files and traceability matrices that demonstrate compliance through objective evidence. • Strong organisational skills, with the ability to prioritise tasks and support effective teamwork. • Excellent technical writing and communication skills. • Analytical, detail-oriented and quality-focused. • Team-oriented and able to work effectively with cross-functional stakeholders. • Able to work under pressure, reprioritise and meet deadlines. • Self-motivated, accountable, flexible and reliable. Special AUD $80,000.00 $90,000.00 Per Annum Superannuation<img src="https://www.jobg8.com/Tracking.aspx?85svR42cVCao%2b9wF%2bQTYm6XRK33glniam" width="0" height="0" />