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Post Market Vigilance Specialist

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Regulatory Affairs
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19000L11 Requisition #
Careers That Change Lives


Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations. The main objective of this role is to ensure compliance of Medical Devices marketed by Medtronic Australasia with Post Market requirements in line with Australia and New Zealand Medical Device Regulations.


A Day in the Life


Activities include (but are not limited to) product holds, execution of field actions and product complaint related activities. The role involves coordination with key internal and external stakeholders within ANZ and overseas.


Key responsibilities include:

  • Follow Medtronic procedures and all other regulatory requirements
  • Execution of Field Corrective Actions including liaison with internal and external stake holders
  • Making Regulatory Reportability Decisions
  • Respond to Regulatory Inquiries (TGA Device Incident Reports)
  • Internal Stakeholder management related to product Complaints, Holds, Recalls (Sales, Marketing, Regulatory, Quality, Operations and 3PLs)
  • Return of products associated with complaints
  • Analysing data of all inventory reports for product hold and field actions
  • Preparation and release of regular reports associated with regulatory actions, and Post Market Surveillance
  • TGA Post Market Reviews


Must Have:
  • 3+ years of experience working within a certified Quality System.
  • Previous experience in either Quality/Regulatory or ideally Post market.


Preferred Experience:

  • Knowledge and understanding of applicable external medical device regulatory standards, including TGA, MedSafe, ISO 13485
  • Demonstrated organization and administrative skills (record keeping and data entry)
  • Competent analytical and computer skills
  • Strong and demonstrable business acumen
  • Ability to multi task and manage complexity
  • Strong Communication & Interpersonal Skills (verbal and written)


About Medtronic


Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.


We can accelerate and advance our ability to create meaningful innovations – but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.


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Change Begins With You

We look for bold ideas and fresh insights - that's what drives innovation. Come drive the future of healthcare with us.

Engineering

The opportunity to invent. The benefit of joining a leader. The power to improve lives. You’ll find all that and more here.

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Sales

Bring life-changing solutions to those who need them. Be rewarded for rewarding work.

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Regulatory

Join us in our challenge to make global healthcare more affordable and accessible. Your insight and oversight will help us create solutions that change the world.

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Read About The
Medtronic Mission.

Our mission “to alleviate pain, restore health, and extend life” is more than a statement. It’s a belief that our employees live every day.

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EMPLOYEE STORY:
ENGINEERING

Alyse is an Engineering Program Manager for Neuromodulation in Minneapolis, Minnesota.

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WONDERING ABOUT
WORKING AT
MEDTRONIC?

Our employees come from varied backgrounds with a common goal—changing lives.

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We value what
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unique.

Join us, and bring the power of your unique point of view to our culture of collaboration and innovation.

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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

WORKING AT
MEDTRONIC

Be part of one of the world’s leading medical technologies and solutions companies.