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Regulatory Affairs and Quality Specialist

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Regulatory Affairs
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19000IGP Requisition #

Careers that Change Lives

A Day in the Life

Responsibilities:


· Handling of routine regulatory and quality related inquiries of Swiss customers and MDT employees
· Processing (incl. translation into English language) of incoming Swiss Competent Authority inquiries
· Support the roll-out of and follow up on 'Field Safety Corrective Actions' in Switzerland
· Execute 'Product Hold Orders' in Switzerland
· Support of the Austrian organization in case of absence of the Austrian counterpart in case of time sensitive activities related to the topics mentioned above
· Monitoring of the Swiss regulatory framework and impact assessment of upcoming changes
· Support maintenance and further development of the QM system according to EN ISO 13485:2016 and ISO 9001:2015
· Support creation, verification and release of QM documents
· Support coordination and monitoring of corrective and preventive actions (CAPA)
· Monitoring and control of suppliers / distributors
· Preparation and analysis of relevant data for regular QM review meetings with management
· Planning and implementation of training courses
· Close cooperation with colleagues within the Swiss Sales Organization as well as international

Requirements

· Knowledge of the relevant medical device legislation and corresponding standards (e.g. EN ISO 13485:2016)
· Degree in Engineering, Life-science, Biology or another relevant degree
· IT skills (standard office management tools)
· Preferably work experience in similar field (e.g. medical device industry or competent authority)
· Language skills: very good command of the German, English (and ideally French) language (spoken and written)
· Communication/Presentation skills
· Analytical/Problem-solving skills

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services 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 want to 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
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.