The role provides strategic guidance to ensure ResMed's products comply with global regulatory frameworks throughout their lifecycle
Job Summary
The role provides strategic guidance to ensure ResMed's products comply with global regulatory frameworks throughout their lifecycle.
This position focuses on evaluating regulated and non-regulated digital health technologies, including AI/ML features, to determine appropriate compliance pathways.
The company fosters a diverse and inclusive culture driven by excellence, encouraging individual expression and innovative ideas.
Matching Summary
The role provides strategic guidance to ensure ResMed's products comply with global regulatory frameworks throughout their lifecycle.
Skills & Requirements
Must-have
Software as a Medical Device (SaMD) experience
FDA 510(k) submission authoring
EU MDR regulatory requirements knowledge
Product lifecycle regulatory strategy
Cross-functional team collaboration
Nice-to-have
AI/ML-enabled medical device experience
Agile software development environment familiarity