Technical Documentation Specialist (Medical Devices & ISO 13485)

SDI Limited; Melbourne; Presencial; AUD 90.000 - 125.000; Jornada completa

Descripción de la vacante

SDI Limited, a Melbourne-based medical devices company, seeks a Technical Documentation Specialist to manage EU MDR/ISO 13485 compliant tech docs for new and legacy devices. The role covers evidence mapping, risk controls and lifecycle documentation, with collaboration across R&D, QA, Regulatory and Marketing.

You will ensure traceability, update templates, and support regulatory submissions and audits in a high‑compliance environment. Bayswater/Montrose location; 38 hours per week.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Design control

Risk management

Verification/validation

Document control

Medical device documentation

5+ years Regulatory Affairs/QA/R&D

MS Word

MS Excel

MS Project

Educación

Degree in a scientific, engineering or related discipline

Herramientas

MS Word

MS Excel

MS Project

Descripción del empleo

Technical Documentation Specialist (Medical Devices & ISO 13485)

We are a Global Business leading the market with Australian made and owned dental restorative products, teeth whitening and small equipment. Founded in 1972, SDI products are now distributed in over 100 countries throughout the world. Our global head office and manufacturing plant is located in Melbourne with overseas branch offices and warehousing in the USA, Brazil and Germany.

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 Responsibilities

• 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 and 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

Essential Qualification/ 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.

Essential Skills, Knowledge and Attributes

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.

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.