Medical Device Technical Documentation Specialist (ISO 13485)

SDI Limited; Australia; Presencial; AUD 80 000 - 90 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Superannuation

Resumo da oferta

SDI Limited is seeking a Technical Documentation Specialist to prepare and maintain EU MDR technical files for medical devices, ensuring traceability and regulatory alignment across product lifecycles.

The role requires collaboration with R&D, QA, Regulatory, Manufacturing and Marketing to embed compliance within processes, and proficiency with MS Word/Excel/Project. Bayswater and Montrose site with 38-hour weeks await a detail-oriented professional.

Qualificações

• Bachelor's degree in a scientific, engineering or related discipline.
• 5+ years’ experience in Regulatory Affairs, Quality Assurance or R&D desirable.
• Experience in EU MDR technical documentation, Annex II/III and GSPR evidence alignment.
• Proficient in MS Word, Excel, MS Project and related software.
• Ability to summarise complex regulatory information clearly.
• Experience with traceability matrices is highly regarded.

Responsabilidades

• Prepare, review and maintain EU MDR technical documentation for new and legacy medical devices.
• Develop and maintain traceability matrices linking regulatory requirements, GSPRs, design inputs/outputs, risks and controls, verification/validation evidence.
• Provide quality and regulatory input to submissions, documentation updates and product lifecycle activities.
• Collaborate with R&D, Manufacturing, Quality, Regulatory and Marketing to embed compliance requirements in processes and documentation.
• Improve technical documentation templates, procedures and tools, including MDR evidence mapping and traceability templates.

Conhecimentos

Technical writing

Regulatory affairs

Cross-functional collaboration

Attention to detail

Planning and prioritization

Formação académica

Bachelor's Degree

Ferramentas

MS Word

MS Excel

MS Project

Descrição da oferta de emprego

SDI Limited is seeking a Technical Documentation Specialist to prepare and maintain EU MDR technical files for medical devices, ensuring traceability and regulatory alignment across product lifecycles.

The role requires collaboration with R&D, QA, Regulatory, Manufacturing and Marketing to embed compliance within processes, and proficiency with MS Word/Excel/Project. Bayswater and Montrose site with 38-hour weeks await a detail-oriented professional.