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International Regulatory Affairs Specialist

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Regulatory Affairs
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20000JL1 Requisition #

INTERNATIONAL REGULATORY AFFAIRS SPECIALIST

The Cardiac Ablation Solutions (CAS) division is focused on disrupting the Electrophysiology (EP) market to be the number one arrhythmia care pathway, cardiac mapping and ablation solutions provider for our customers and patients. Inspired by the Medtronic mission and dedicated to transforming the lives of people with cardiac arrhythmias, to date CAS has transformed the lives of almost 1 million patients.

Careers that Change Lives

The International Regulatory Affairs (RA) Specialist will plan and execute global regulatory activities (e.g. submissions, STED updates, change assessments) necessary to obtain and maintain regulatory approvals within International markets.  This position ensures compliance with required global regulations and Medtronic policies and serves as a key team member and/or in a lead role on extended team(s).

A Day In The Life

  • Provide support to the Geography RA who interact with regulatory authorities to assure timely new product introductions and continued product access
  • Work on Product Development and Released Product Engineering teams, providing inputs to International regulatory strategy and execution
  • Assist in keeping company informed of regulatory requirements in International markets
  • Provides regulatory review of labeling, design changes, and specification changes as it relates to specific geographies
  • Work with Geography RA teams to develop International regulatory strategies for product submissions, identifying needs for bench, animal and clinical testing.
  • Author Product Summary Technical Documentation (STED). Supports Geography RA team to prepare International submissions and obtain product approval/clearance to include assistance with government queries and registration documentation requirements
  • Ensures relevant FDA and International import/export requirements are met, as required
  • Supports International product demand planning and release activities
  • Reviews Change Orders and assess regulatory impact of product changes on International regulatory strategy and submissions per standard procedures
  • Supports post market regulatory compliance activities for International product approvals
  • Develops and maintains regulatory affairs department procedures and process improvements
  • Other duties as assigned or required

Must Have: Minimum Requirements

  • Bachelors degree required
  • Minimum of 2 years of regulatory affairs or quality experience, or advanced degree with 0 years of regulatory affairs or quality experience

Nice to Have

  • US and/or International medical device regulatory submission/approval experience
  • Knowledge of FDA/EU/MHLW/TGA and/or other Int’l regulations/requirements.
  • Strong Interpersonal and analytical skills
  • Strong communication skills
  • Attention to detail
  • Strong Technical Writing 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.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

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Challenge 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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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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Be part of work that matters. 75 million patients had their health improved by our products last year.

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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.

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