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MDR/Vigilance Specialist

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Quality
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19000GJE Requisition #
MEDTRONIC
At Medtronic, we value what makes you unique. Be part of a company that thinks differently to solve problems, make progress and deliver meaningful innovations

OUR PURPOSE
At our Product Experience Management (PXM) group, which is part of the Galway PXM Complaint Handling and Regulatory Reporting Department in Medtronic, plc, we focus on complaint handling and post market regulatory reporting activities for a wide range of Medtronic products. You will be part of a high performing Complaint Handling and Medical Device Regulatory reporting department, which provides value throughout the Product Life cycle through world class execution in Medical Device Reporting and Vigilance compliance

Come for a job, stay for a career!

A DAY IN THE LIFE OF:

• Monitors the company's drug or medical devices surveillance program including the intake from all sources , evaluation, processing, and follow-up on complaints and adverse reports, participation in the resolution of any legal liability and in complying with government regulations.
• Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), or adverse reaction data as required by regulatory agencies
• Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements
• Support the response to any queries received from regulatory agencies in relation to complaint events or post market regulatory reports
• Support complaint trend analysis and annual post market surveillance reports for various products
support complaint handling harmonization initiatives with other Medtronic sites globally
contribute to continuous improvement activities to support the role out of cell operating systems and principles within the PXM department
• support problem solving initiatives within the department and coach or mentor other team members.


KEY SKILLS & EXPERIENCE
• We are looking for a qualified person to Bachelor’s degree (Level 8 NFQ) in Engineering/Science or related discipline and preferably with 2-3 years relevant experience in a medical devices or related environment.
• Candidates with a legal or clinical qualification (e.g. registered nurse or experience in physiological or clinical measurement science) will also be considered.
• We are looking for a dynamic team player who can work effectively and proactively on cross-functional teams.
• Experience/understanding of complaint handling or CAPA processes are desirable. Candidates must be able to think critically and make sound decisions.
• Candidates must be focused on patient safety and customer service, set high standards, instils operational excellence, drive accountability and model ethical behavior. Candidates must be a good communicator and are fluent in English, both in writing and speaking.

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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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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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Medtronic Mission.

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EMPLOYEE STORY:
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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
makes you
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.