Anz Ra Leader

1 week ago

Mascot, Australia GE HEALTHCARE Full time

Job Description Summary:
This position provides guidance to Australia and New Zealand (ANZ).

The individual would be working with a team of Regulatory Affairs professionals to ensure GE HealthCare achieves compliance to applicable regulations.

The individual would be involved with regulatory activities in the areas such as premarket submissions, post-market reporting, regulatory intelligence, advertisement review, product compliance, etc.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits.

Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.


Essential Responsibilities:

  • Provides regulatory input during product development and ensure product compliance
  • Develops regulatory strategies and help navigate regulatory submission route map
  • Works with a cross functional team to achieve regulatory excellence
  • Reviews and assesses changes in existing products to determines for new registration and/or license revision
  • Plans for renew submission in applicable countries per business needs, to ensure product supply continuity in those countries.
  • Reviews and approves advertising material to ensure compliance with approved claims and/or other regulatory requirements.
  • Performs environment scan for new regulatory requirements and organize regulatory intelligence for impact assessment
  • Supports regulatory inspections/audit as required.
  • Assess adverse event reportability and perform post market reporting as per country regulations.
  • Identify issues impacting project progression and work with manager to recommend improvements to correct or accelerate project progression
  • Establish effective and clear communication within RA and other relevant stakeholder and functions
  • Ensure proper documentation in compliance with QMS requirement

Qualifications/Requirements:

  • Ability to communicate effectively in English (both written and oral)
  • Good communication skills
  • 10+ years working experience as regulatory affairs in medical device company is preferred. Regulatory Affairs Certification (RAPS) is preferred
  • Australia TGA experience is preferred

Desired Characteristics:

  • Ability to work independently in fastpaced environment with little supervision
  • Ability to adapt to constant change and influence positive change effectively
  • Teamoriented and responsive to customer needs
  • Attention to detail and resultsOriented
  • Down to earth, practical, and patient


Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities.

Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.


  • Flexible working options and flexible hours
  • Competitive salary
  • 5 weeks leave (ask about "take 5")
  • Generous leave & family policies
  • Long term career opportunities (locally and globally)
  • Generous discounts for goods & services via our employee benefits program (think travel, entertainment & shopping) *This was recently rated as one of our employees favourite benefits
LI-BA1

LI-ONSITE

LI-HYBRID

Additional Information:

Relocation Assistance Provided:
No

  • Anz Ra Leader

    3 weeks ago

    Mascot, Australia GE HEALTHCARE Full time

    **Job Description Summary**: This position provides guidance to Australia and New Zealand (ANZ). The individual would be working with a team of Regulatory Affairs professionals to ensure GE HealthCare achieves compliance to applicable regulations. The individual would be involved with regulatory activities in the areas such as premarket submissions,...

  • Aka Ra Manager

    3 days ago

    Mascot, Australia GE Healthcare Full time

    **Job Description Summary**: The AKA RA Manager Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. The AKA RA Manager has in-depth knowledge of best...

  • Aka Ra Manager

    2 weeks ago

    Mascot, Australia GE Healthcare Full time

    Job Description Summary: The AKA RA Manager Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. The AKA RA Manager has in-depth knowledge of best practices...

  • Aka Ra Program Manager

    3 weeks ago

    Mascot, Australia GE Healthcare Full time

    **Job Description Summary**: We are the doers. The leaders. The makers. The change-bringers. We are all different, uniting to solve the world’s toughest challenges. Our teams are hungry to make history, acting with integrity to relentlessly improve people’s lives. With every weld, every sale, and every code we write we keep the world in motion. It’s...

  • ANZ RA Director

    1 month ago

    Mascot, Australia GE Healthcare Full time

    Job Description SummaryProvides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies in ANZ. Interprets simple internal and external business challenges and recommends best...

  • Aka Ra Program Manager

    1 week ago

    Mascot, Australia GE Healthcare Full time

    Job Description Summary: We are the doers. The leaders. The makers. The change-bringers. We are all different, uniting to solve the world's toughest challenges. Our teams are hungry to make history, acting with integrity to relentlessly improve people's lives. With every weld, every sale, and every code we write we keep the world in motion. It's time to stop...

  • Communications Leader, Anz

    2 weeks ago

    Mascot, Australia GE HEALTHCARE Full time

    **Job Description Summary**: Provides a broad range of communications functions and services across a unit or units which can be at various levels within the organization. Partners with business leadership to ensures the performance of communications generalist activities. The Communications Leader for GE HealthCare, Australia & New Zealand is a key member...

  • Ccs Technical Support Leader

    2 months ago

    Mascot, Australia GE Healthcare Full time

    **Job Description Summary**: The CCS (LCS and US) Technical Support Leader is responsible for leading the technical support function for customers and field teams to minimise the customer events at each site through constant analysis, field interventions to rectify corrective repairs with urgency and effectiveness, whilst maintaining a disciplined cost...

  • Service Imaging Product Leader

    3 weeks ago

    Mascot, Australia GE HEALTHCARE Full time

    **Job Description Summary**: As the Service Imaging Product Leader, you will be responsible for leading the development and execution of product strategies for Imaging Accessory products. You will work closely with cross-functional teams to develop plans that improve the customer experience, increase profitability and drive growth. This role will integrate...

  • Supply Chain Manager

    4 weeks ago

    Mascot, Australia Eaton Full time

    Eaton is an intelligent power management company dedicated to improving the quality of life and protecting the environment for people everywhere. Today, the world runs on critical infrastructure and technology. Planes, hospitals, factories, data centres, the electrical grid; these are things people depend on every day, and the companies behind them depend on...

  • Supply Chain Manager

    2 months ago

    Mascot, Australia EATON Full time

    Eaton is an intelligent power management company dedicated to improving the quality of life and protecting the environment for people everywhere. Today, the world runs on critical infrastructure and technology. Planes, hospitals, factories, data centres, the electrical grid; these are things people depend on every day, and the companies behind them depend on...

  • Supply Chain Manager

    2 weeks ago

    Mascot, Australia EATON Full time

    Eaton is an intelligent power management company dedicated to improving the quality of life and protecting the environment for people everywhere. Today, the world runs on critical infrastructure and technology. Planes, hospitals, factories, data centres, the electrical grid; these are things people depend on every day, and the companies behind them depend on...

  • Service Director, Anz

    4 weeks ago

    Mascot, Australia Kone Full time

    Reporting to the Managing Director for ANZ, you will lead and inspire the Australia and New Zealand “Service” arm of the business. You will drive results through business growth, customer loyalty and operational excellence. You will use your leadership ability and commercial acumen to engage operational, sales and technical support teams across multiple...

  • Service Director, Anz

    4 weeks ago

    Mascot, Australia Kone Full time

    Reporting to the Managing Director for ANZ, you will lead and inspire the Australia and New Zealand “Service” arm of the business. You will drive results through business growth, customer loyalty and operational excellence. You will use your leadership ability and commercial acumen to engage operational, sales and technical support teams across multiple...

  • Service Director, Anz

    2 weeks ago

    Mascot, Australia Kone Full time

    Reporting to the Managing Director for ANZ, you will lead and inspire the Australia and New Zealand "Service" arm of the business. You will drive results through business growth, customer loyalty and operational excellence.You will use your leadership ability and commercial acumen to engage operational, sales and technical support teams across multiple...

  • Talent Acquisition Manager, Anz

    4 weeks ago

    Mascot, Australia Kone Full time

    At KONE, you’ll find innovation that goes somewhere We see a future of smart cities. As an innovation leader in the elevator and escalator industry, our award-winning products and solutions continue to push boundaries, rethinking how we use buildings for life, work and play. The Future of Work is Flexibility Our work will take you in different...

  • Talent Acquisition Manager, Anz

    4 weeks ago

    Mascot, Australia Kone Full time

    At KONE, you’ll find innovation that goes somewhere We see a future of smart cities. As an innovation leader in the elevator and escalator industry, our award-winning products and solutions continue to push boundaries, rethinking how we use buildings for life, work and play. The Future of Work is Flexibility Our work will take you in different...

  • Talent Acquisition Manager, Anz

    1 week ago

    Mascot, Australia Kone Full time

    At KONE, you'll find innovation that goes somewhereWe see a future of smart cities. As an innovation leader in the elevator and escalator industry, our award-winning products and solutions continue to push boundaries, rethinking how we use buildings for life, work and play.The Future of Work is FlexibilityOur work will take you in different directions.Due to...

  • Ccs Technical Support Leader

    1 week ago

    Mascot, Australia GE Healthcare Full time

    Job Description Summary: The CCS (LCS and US) Technical Support Leader is responsible for leading the technical support function for customers and field teams to minimise the customer events at each site through constant analysis, field interventions to rectify corrective repairs with urgency and effectiveness, whilst maintaining a disciplined cost...

  • Resource Allocator

    3 weeks ago

    Mascot, Australia dnata catering Full time

    **Do you want a high-flying career working for the world’s largest** **Air Services provider?** We have an exciting opportunity available for a **Resource Allocator - Team Leader** to join our high performance national Workforce Planning team based in either SYD/MEL/PER on a **full-time permanent **basis. **More about this role**: To put it simply, as...