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Senior Regulatory Affairs Specialist

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Regulatory Affairs
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19000C9X 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 Regulatory Affairs department in Medtronic, plc, we focus on harnessing our collective strength to deliver best-in-class solutions that benefit patients and our cross functional partners. Senior Regulatory Affairs Specialists are directly involved in regulatory activities supporting the global commercialization and sustaining of products on the market in compliance with all regulatory requirements.

Come for a job, stay for a career!

A DAY IN THE LIFE OF:

• As part of a team of regulatory affairs professionals you provide regulatory support for new products/therapies and changes to existing products. Work with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
• Prepare regulatory submissions for new products and product changes as required to ensure timely approvals for market release and/or clinical studies.
• Provide post market maintenance support to commercial products as necessary to ensure ongoing regulatory approval. This includes supporting global re-certification activity, reviewing labeling, promotional material, product changes and documentation for changes requiring government approval. Prepare submissions and reports for filing directly with EU & US regulatory agencies and support other international agencies as required by product status.
• Interact directly with external regulatory agencies (FDA, notified bodies etc.) and/or indirectly with international regulatory agencies on applicable projects/products.
• Support regulatory compliance activities, including manufacturing site registration & regulatory agency audits as needed.
• Maintain proficiency in worldwide regulatory requirements; establish and maintain good relationships with agency personnel.
• Develop internal procedures to ensure continuous compliance with all regulatory requirements.
• Identify and develop best practices within the Regulatory Affairs department including continuous development initiatives (MOS/COS)
• Ensure personal understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance and high-quality work.

KEY SKILLS & EXPERIENCE
• We are looking for a qualified person to Level 8 Bachelor’s Degree/Masters or equivalent in Science, Engineering or related discipline.
• Regulatory experience is desirable, however, candidates with a minimum of 5 year’s relevant experience will also be considered.
• You are a dynamic team player and can work effectively and pro-actively on activities both individually and in teams.
• You are experienced with Microsoft Word, Excel and PowerPoint, and knowledge of Adobe Acrobat, Data Management Systems are desirable
• You have strong technical knowledge. You are skilled in thinking critically and making sound decisions.
• You collaborate with others and create alignment with team members.
• You set high standards and drive accountability in the execution of your responsibilities and you model ethical behavior.
• You are a good communicator and fluent in English, both in writing and speaking with strong organizational skills.

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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.