Medical Device Technical Documentation Specialist (EU MDR/ISO 13485)

SDI Limited; City of Knox; Presencial; AUD 90.000 - 130.000; Jornada completa

Descripción de la vacante

SDI Limited, a global dental products company, is seeking a Technical Documentation Specialist (Medical Devices & ISO 13485) to manage compliant technical files and evidence mapping across the product lifecycle. The role supports new and legacy devices while ensuring regulatory alignment with EU MDR, FDA, and ISO standards.

Work locations include Bayswater and Montrose, with a 38-hour work week. The ideal candidate holds a science/engineering degree and 5+ years in Regulatory Affairs, QA, or

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 EU MDR technical documentation, 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 R&D 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 and evidence-based.
• Ensures documentation demonstrates compliance with EU MDR Annex II/III, GSPRs, FDA 21 CFR Part 820 and ISO 13485.
• Develops and maintains traceability matrices linking regulatory requirements, design inputs/outputs, risks and controls.
• 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 in processes and documentation.
• Improves technical documentation templates, procedures and tools including MDR evidence mapping.

Conocimientos

Regulatory compliance

Technical writing

Cross-functional collaboration

Attention to detail

Educación

Bachelors in science/engineering or related

Herramientas

MS Word

MS Excel

MS Project

Descripción del empleo

SDI Limited, a global dental products company, is seeking a Technical Documentation Specialist (Medical Devices & ISO 13485) to manage compliant technical files and evidence mapping across the product lifecycle. The role supports new and legacy devices while ensuring regulatory alignment with EU MDR, FDA, and ISO standards.

Work locations include Bayswater and Montrose, with a 38-hour work week. The ideal candidate holds a science/engineering degree and 5+ years in Regulatory Affairs, QA, or