Senior Regulatory Specialist for Growth Opportunities

3 days ago

Sydney, New South Wales, Australia beBeeRegulatory Full time
Job Title:
Senior Regulatory Specialist for Growth Opportunities

The primary role of this position is to provide regulatory support and guidance across various stages of product life cycles. Key deliverables include ensuring compliance and implementing optimal regulatory strategies for portfolio planning, active regulatory intelligence, and execution excellence.

This includes establishing systems and processes to enable timely and compliant access to global markets. The Senior Regulatory Specialist will work closely with internal stakeholders and external regulators to achieve business goals.

This position requires a strong understanding of regulatory frameworks and the ability to interpret device-specific requirements. The ideal candidate will have experience leading or coordinating global regulatory submissions and possess excellent communication and project planning skills.

In this role, you will be responsible for defining regulatory strategies, authoring and reviewing global regulatory submissions, and collaborating with cross-functional teams to resolve submission blockers.

You will also serve as a mentor to junior team members and contribute to process improvements and best practices in regulatory affairs.

This is an exciting opportunity to join a dynamic team and make a significant impact on the company's growth and success.

Bachelor's degree in biomedical engineering, regulatory affairs, life sciences, or related discipline required. 5+ years of experience in Regulatory Affairs within a regulated industry preferred.

Familiarity with device-specific standards and submission platforms is highly desirable.

This position offers a challenging and supportive work environment where you can apply your technical expertise and analytical rigor to drive regulatory excellence and innovation.

  • Senior Specialist Regulatory Affairs

    2 weeks ago

    Sydney, New South Wales, Australia ResMed Inc Full time

    Senior 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

    2 weeks ago

    Sydney, New South Wales, Australia ResMed Inc Full time

    Senior 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 Regulatory Compliance Specialist

    2 days ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $110,000 - $140,000

    Senior Regulatory Compliance SpecialistThis role is for a highly effective project manager to lead and manage regulatory processes for cultured meat products.Develop and manage project plans for regulatory approval processes for cultured meat products, ensuring timely and successful completion.Ensure adherence to existing food safety regulations and...

  • Senior Regulatory Compliance Specialist

    2 days ago

    Sydney, New South Wales, Australia beBeeCompliance Full time $166,000 - $190,000

    Regulatory Compliance SpecialistWe seek a seasoned professional to manage product compliance in Australia and New Zealand.Key Responsibilities:Develop and implement product compliance strategies.Collaborate with cross-functional teams to ensure regulatory requirements are met.Conduct risk assessments and identify areas for improvement.Requirements:Strong...

  • Senior Specialist Regulatory Affairs

    2 weeks ago

    Sydney, New South Wales, Australia ResMed Full time

    About 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...

  • Regulatory Specialist

    3 days ago

    Sydney, New South Wales, Australia Buscojobs Full time

    Coal LSL Newcastle, New South Wales, AustraliaJoin or sign in to find your next jobJoin to apply for the Regulatory Specialist role at Coal LSLCoal LSL Newcastle, New South Wales, Australia1 day ago Be among the first 25 applicantsJoin to apply for the Regulatory Specialist role at Coal LSLGet AI-powered advice on this job and more exclusive features.What...

  • Senior Specialist Regulatory Affairs

    7 hours ago

    Sydney, New South Wales, Australia ResMed Full time

    About 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

    2 weeks ago

    Sydney, New South Wales, Australia ResMed Full time

    About 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 Regulatory Compliance Specialist

    2 days ago

    Sydney, New South Wales, Australia beBeeCompliance Full time $110,000 - $115,000

    Regulatory Change Manager Position OverviewThe Regulatory Change Manager will be responsible for monitoring and analyzing regulatory changes impacting the superannuation industry.Key Responsibilities:Monitor and analyze regulatory changes impacting the superannuation industry to ensure alignment with compliance obligationsConduct comprehensive impact...

  • Regulatory Submission Specialist

    4 weeks ago

    Sydney, New South Wales, Australia PSI CRO AG Full time

    Regulatory Submission Specialist (18-months contract)Regulatory Submission Specialist (18-months contract)2 weeks ago Be among the first 25 applicantsCompany DescriptionWe are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together 3000...