Senior Regulatory Specialist
2 weeks ago
This position offers an exceptional opportunity to lead regulatory activities across international markets, driving product registrations and ensuring compliance obligations are met.
As a seasoned senior RA professional or an experienced lead seeking a new challenge, you'll collaborate with cross-functional teams to drive commercial initiatives and support market expansion plans.
Key responsibilities include leading and coordinating regulatory submissions, renewals, and product lifecycle activities, as well as managing post-market compliance obligations and providing timely regulatory input to support commercial initiatives.
Acting as the regulatory point of contact during audits and inspections from relevant authorities and certification bodies, you'll ensure alignment with global regulatory strategies and keep internal stakeholders informed of changing regulatory requirements.
In addition, you'll contribute to the continuous improvement of internal regulatory processes and systems.
Requirements- Tertiary qualifications in regulatory affairs, engineering, science, or a related field.
- Strong stakeholder engagement skills, with the ability to collaborate effectively across commercial, marketing, and senior leadership teams.
- Confident communicator when working with external regulatory bodies, notified bodies, consultants, and third-party representatives.
- 3-5 years experience working with medical device regulations in APAC & EMEA markets.
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Senior Specialist Regulatory Affairs
2 weeks 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...
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Senior Specialist Regulatory Affairs
2 weeks 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...
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Senior Specialist Regulatory Affairs
2 weeks 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...
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Senior Specialist Regulatory Affairs
2 weeks 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 masks, CPAP...
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Senior Regulatory Specialist, Asia Pacific
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Senior Regulatory Specialist
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Senior Specialist Regulatory Affairs
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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...
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Senior Regulatory Compliance Specialist
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Regulatory Relations Senior Specialist
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