Location Country
Australia
Vacancy Name
Technical Documentation Specialist (Medical Devices & ISO 13485)
Employment Type
Full-Time
Division
Production Quality
Summary of Role
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.
Contributing towards SDI Strategic Priorities.
Conducting work in a safe manner, adhering to quality compliance requirements and demonstrating a strong commitment to SDI's values of passion, accountability, respect, teamwork, and innovation.
Specific Responsibilites
Prepares, reviews and maintains technical file documentation for new and legacy medical devices, ensuring content is clear, complete, evidence-based and suitable for regulatory submission or audit review.
Ensures 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.
Develops and maintains traceability matrices linking regulatory requirements, GSPRs, design inputs/outputs, risks and controls, verification/validation evidence, labelling, claims and post-market data.
Provides quality and regulatory input to submissions, technical documentation updates, design changes and product lifecycle activities.
Collaborates with R&D, Manufacturing, Quality, Regulatory and Marketing to embed compliance requirements in relevant processes and documentation.
Improves technical documentation templates, procedures and tools, including MDR evidence mapping and technical file traceability templates.
Supports Quality activities and ensures work is performed in accordance with the QMS, ISO 13485, MDSAP, EU MDR and other applicable requirements.
Supports risk management, design control and periodic standards review, including assessment of regulatory or standards changes that may impact products or technical documentation.
Key Relationships (Internal & External)
External – Equipment suppliers, laboratories, research organisations, consultants and regulators.
Internal – R&D, QA, QC, Regulatory Affairs, Manufacturing and Marketing.
Job Environment
The position is located at Bayswater and Montrose
Working hours: 38 hours per week
Education Level
Bachelor's Degree
Essential Experience
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.
Knowledge and skills
Aware of SDI’s current Quality policy and objectives.
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.
Personal Qualities
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.
Classification Level
Special
Salary Minimum
$80,000.00
Salary Maximum
$120,000.00
