Compliance Engineer

Resmed

Sydney

2 days ago

Sydney

2 days ago

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Compliance Engineer

ResMed's Digital Engineering Product Development team seeks a Compliance Engineer to support SaMD and health software development. Collaborate with software engineering teams to ensure regulatory, safety, and cybersecurity compliance. Serve as SME during audits, develop risk management plans, and maintain traceability.

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On-site

Full-time

Mid Level

SaMD

ISO 13485

Salary

Not specified

Work Location

Sydney, New South Wales, Australia, AU

Work Model

On-site

Experience Required

3 years

Employment Type

Full-time

Experience Level

Not Applicable

Core Qualifications

Technical (Must-have)

SaMDISO 13485EU MDRMDSAPHDSSOC 2HITRUSTRisk ManagementSoftware Development Lifecycle (SDLC)Cybersecurity

Soft Skills

technical analysisaptitude for clinical workflowscommunicationcollaboration

Key Responsibilities

•Serve as the primary Subject Matter Expert (SME) during internal and external audits for assigned products.
•Develop Risk Management Plans and perform safety and cybersecurity risk analyses in collaboration with Software Engineering and Medical Affairs teams.
•Manage product requirement specifications and maintain traceability matrices.
•Lead technical design reviews for new product introductions and product enhancements.
•Prepare comprehensive release documentation to support change management requirements.
•Conduct post-market risk assessments on product defects and incidents.
•Evaluate third-party software libraries and tools for integration into development workflows.
•Perform gap analyses against new or updated regulations and industry standards.
•Update and improve Quality Management System (QMS) procedures to enhance compliance and operational efficiency.

Compliance EngineerMedical DeviceSoftware as a Medical DeviceRegulatoryQuality Management SystemRisk ManagementAuditSydneyResMedHealth Technology

Key Responsibilities

•Serve as the primary Subject Matter Expert (SME) during internal and external audits for assigned products.

•Develop Risk Management Plans and perform safety and cybersecurity risk analyses in collaboration with Software Engineering and Medical Affairs teams.

•Manage product requirement specifications and maintain traceability matrices.

•Lead technical design reviews for new product introductions and product enhancements.

•Prepare comprehensive release documentation to support change management requirements.

•Conduct post-market risk assessments on product defects and incidents.

•Evaluate third-party software libraries and tools for integration into development workflows.

•Perform gap analyses against new or updated regulations and industry standards.

•Update and improve Quality Management System (QMS) procedures to enhance compliance and operational efficiency.