Location Country

Australia

Vacancy Name

Technical Documentation Specialist (Medical Devices & ISO 13485)

Vacancy No

VN420

Employment Type

Full-Time

Duration

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.

- Robust 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

Currency

AUD

Salary Minimum

$80,000.00

Salary Maximum

$120,000.00

Salary Period

Per Annum

Benefits

Superannuation

📌 Technical Documentation Specialist (Medical Devices & ISO 13485) (Australia)
🏢 SDI
📍 Australia