The primary role of the Regulatory Affairs function is to provide support and guidance with respect to the regulatory environment, at all stages of the life cycle of ResMed's products
Job Summary
The primary role of the Regulatory Affairs function is to provide support and guidance with respect to the regulatory environment, at all stages of the life cycle of ResMed's products.
This role supports software-driven and digital health solutions, including Software as a Medical Device (SaMD) and algorithm-driven functionality (including AI/ML-enabled features).
Working closely with all internal stakeholders and external regulators to achieve business goals.
Matching Summary
The primary role of the Regulatory Affairs function is to provide support and guidance with respect to the regulatory environment, at all stages of the life cycle of ResMed's products.
Skills & Requirements
Must-have
Software as a Medical Device (SaMD) experience
AI/ML-enabled features evaluation
Global regulatory requirements translation
Cross-functional team regulatory partnership
Product lifecycle regulatory strategy
Nice-to-have
Cybersecurity and data privacy considerations
Agile software development environments
Networking with senior external personnel
Training and mentoring junior staff
Key Requirements
Bachelor’s degree
Minimum of 3 years of related experience
Experience with SaMD and/or digital health products
Experience authoring FDA regulatory submissions
Experience with EU MDR regulatory requirements
Experience authoring regulatory assessments for product and software changes
Experience authoring regulatory strategy and submissions across the product lifecycle