Senior Regulatory Affairs Specialist
11 hours ago
The Regulatory Affairs team plays a crucial role in shaping regulatory strategy and submission execution for physical products. As a Senior Specialist, you will lead submission planning and execution, influencing design documentation and contributing to regulatory strategy.
You will collaborate across functions to drive global submission readiness, change assessments, and technical documentation that meet diverse market requirements.
This role requires strong analytical skills, the ability to communicate complex ideas effectively, and a passion for driving compliance.
Responsibilities- Author and review global regulatory submissions including FDA 510(k), CE MDR, TGA ARTG, and Health Canada dossiers.
- Interpret device-specific requirements and translate them into clear, well-supported regulatory documentation.
- Align with Regional RA to ensure reusable, scalable submission approaches and consistent technical content.
- Lead regulatory assessments of design and process changes, performing significance evaluations and preparing documentation updates.
To be successful in this role, you will need:
- Bachelor's degree in biomedical engineering, regulatory affairs, life sciences, or related discipline.
- 5+ years of experience in Regulatory Affairs within a regulated industry.
- Proven experience leading or coordinating global regulatory submissions.
- Strong knowledge of ISO 13485, ISO 14971, design control frameworks, and relevant market-specific regulations.
You are a technical expert who can clarify complex ideas and influence others to achieve results. You thrive in structured environments and consistently deliver compliant, high-quality documentation.
-
Senior Specialist Regulatory Affairs
3 hours ago
Sydney, New South Wales, Australia ResMed Inc Full timeSenior Specialist Regulatory Affairs page is loaded## Senior Specialist Regulatory Affairslocations: Sydney, NSW, Australiatime type: Full timeposted on: Posted Todayjob requisition id: JR\_043232**About ResMed**The Sydney RPSD team leads regulatory strategy and delivery for physical products where ResMed Pty Ltd is the legal manufacturer, including...
-
Senior Specialist Regulatory Affairs
3 weeks ago
Sydney, New South Wales, Australia ResMed Inc Full timeSenior Specialist Regulatory Affairs page is loadedSenior Specialist Regulatory AffairsApply locations Sydney, NSW, Australia time type Full time posted on Posted Yesterday job requisition id JR_043232About ResMedThe Sydney RPSD team leads regulatory strategy and delivery for physical products where ResMed Pty Ltd is the legal manufacturer, including masks,...
-
Senior Specialist Regulatory Affairs
21 hours ago
Sydney, New South Wales, Australia Resmed Full timeOverviewThe Sydney Regulatory Affairs team leads regulatory strategy and submission execution for physical products where ResMed Pty Ltd is the legal manufacturer, including masks, CPAP devices, ventilators, and accessories. The team supports both New Product Introduction (NPI) and Product Lifecycle Engineering (PLE) across high-volume, global portfolios....
-
Senior Specialist Regulatory Affairs
19 hours ago
Sydney, New South Wales, Australia Resmed Full timeOverviewThe Sydney Regulatory Affairs team leads regulatory strategy and submission execution for physical products where ResMed Pty Ltd is the legal manufacturer, including masks, CPAP devices, ventilators, and accessories. The team supports both New Product Introduction (NPI) and Product Lifecycle Engineering (PLE) across high-volume, global portfolios....
-
Senior Specialist Regulatory Affairs
3 weeks ago
Sydney, New South Wales, Australia ResMed Inc Full timeSenior Specialist Regulatory Affairs page is loadedSenior Specialist Regulatory AffairsApply locations Sydney, NSW, Australia time type Full time posted on Posted Yesterday job requisition id JR_043232About ResMedThe Sydney RPSD team leads regulatory strategy and delivery for physical products where ResMed Pty Ltd is the legal manufacturer, including masks,...
-
Regulatory Affairs Specialist
13 hours ago
Sydney, New South Wales, Australia beBeeRegulatoryAffairs Full time $90,000 - $110,000Regulatory Affairs SpecialistWe are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to support our organization in delivering regulatory submissions on time.Key Responsibilities:Deliver regulatory submissions within required timeframes;Ensure databases and systems are accurate and current by drafting, updating, reviewing and...
-
Senior Specialist Regulatory Affairs
2 weeks ago
Sydney, New South Wales, Australia ResMed Full timeAbout Res Med The Sydney RPSD team leads regulatory strategy and delivery for physical products where Res Med Pty Ltd is the legal manufacturer, including masks, CPAP devices, ventilators, and accessories.The team supports both New Product Introduction (NPI) and Product Lifecycle Engineering (PLE) across high-volume, global portfolios.As an individual...
-
Senior Specialist Regulatory Affairs
3 days ago
Sydney, New South Wales, Australia ResMed Full timeAbout ResMedThe Sydney RPSD team leads regulatory strategy and delivery for physical products where ResMed Pty Ltd is the legal manufacturer, including masks, CPAP devices, ventilators, and accessories. The team supports both New Product Introduction (NPI) and Product Lifecycle Engineering (PLE) across high-volume, global portfolios.As an individual...
-
Senior Specialist Regulatory Affairs – Incubation
21 hours ago
Sydney, New South Wales, Australia Resmed Full timeSenior Specialist Regulatory Affairs – Incubation & GrowthThe primary role of the Regulatory Affairs function is to provide support and guidance with respect to regulatory environment, at all stages of the life cycle of ResMed's products. Key deliverables include adding value to business through ensuring compliance and delivery of optimal regulatory...
-
Senior Specialist Regulatory Affairs – Incubation
19 hours ago
Sydney, New South Wales, Australia Resmed Full timeSenior Specialist Regulatory Affairs – Incubation & GrowthThe primary role of the Regulatory Affairs function is to provide support and guidance with respect to regulatory environment, at all stages of the life cycle of ResMed's products. Key deliverables include adding value to business through ensuring compliance and delivery of optimal regulatory...
