## Job Details: Technical Documentation Specialist (Medical Devices & ISO 13485)Full details of the job.| | || --
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- || | 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 recent 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 |

📌 Technical Documentation Specialist (Australia)
🏢 SDI
📍 Australia