Compliance Engineer
Resmed
Sydney
4 weeks ago
Compliance Engineer
ResMed is seeking a Compliance Engineer to support the development of Software as a Medical Device (SaMD) and health software applications. The role involves collaborating with software engineering teams to ensure products meet regulatory, safety, and cybersecurity standards, and serving as the subject matter expert during audits.
On-site
Full-time
Mid Level
ISO 13485
EU MDR
Salary
Not specified
Core Qualifications
Technical (Must-have)
ISO 13485EU MDRMDSAPHDSSOC 2HITRUSTSDLCRisk ManagementCybersecuritySoftware Development Lifecycle
Soft Skills
collaborationanalytical skillscommunicationproblem-solvingattention to detail
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 DeviceSaMDQuality ManagementCybersecurityISO 13485EU MDRAuditSydneyOn-site