Senior Global Regulatory Affairs Specialist
7 days ago
This is an exciting opportunity to join a global team as a Senior Specialist in Regulatory Affairs. You will be responsible for authoring and reviewing global regulatory submissions, guiding change assessments, and mentoring team members on the application of global regulations.
Key Responsibilities:- Author and review global regulatory submissions including FDA 510(k), CE MDR, TGA ARTG, and Health Canada dossiers for masks, CPAP devices, and ventilators.
- Interpret device-specific requirements (e.g., ISO 17510, ISO 80601, ISO 18562) and translate them into clear, well-supported regulatory documentation.
- Align closely with Regional RA to ensure reusable, scalable submission approaches and consistent technical content.
- Bachelor's degree in biomedical engineering, regulatory affairs, life sciences, or related discipline.
- 5+ years of experience in Regulatory Affairs within a regulated industry (preferably medical devices).
- Proven experience leading or coordinating global regulatory submissions (e.g., 510(k), CE Marking, TGA ARTG).
You will work closely with cross-functional teams to deliver high-quality regulatory submissions that meet global regulatory requirements.
What We Offer:- A collaborative and dynamic work environment.
- Opportunities for professional growth and development.
- A competitive salary and benefits package.
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Sydney, New South Wales, Australia beBeeRegulatory Full time $100,000 - $140,000Job DescriptionThe 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...
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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....
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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....
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