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Compliance
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19000BXL Requisition #
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Careers that Change Lives
The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.

AORTIC AND PERIPHERAL offers treatment for vascular abdominal and thoracic aortic disease and interventional devices used to treat Peripheral Artery Disease (PAD) through catheter-based procedures and diagnostic technologies.
 
CARDIAC RHYTHM AND HEART FAILURE offers devices and therapies to treat abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions.

CORONARY AND STRUCTURAL HEART provides interventional devices to treat coronary arteries that are blocked by atherosclerotic plaque and devices and therapies to treat structural defects of the heart.

A Day in the Life

Responsibilities may include the following and other duties may be assigned.

  • Oversee the global execution of the global FCA plan to ensure adherence to plan actions and milestones by working cross functionally and with international partners.
  • Provide weekly FCA status updates
  • Draft FCA status updates to regulators as needed
  • Lead cross functional teams to facilitate the development, review and approval of global Field Corrective Action (FCA) Plans.
  • Facilitate the development of FCA materials (letters, presentations, etc…) to effectively communicate relevant information to appropriate customers (e.g. health care providers, risk managers, hospital personnel, patients) and Medtronic field personnel to mitigate patient risks.
  • Identify FCA strategies, actions and milestones to be included in the FCA plan.
  • Work with regulatory contacts to identify, plan and coordinate notifications to regulatory bodies and respond to regulatory and field inquiries in a timely fashion.
  • Coordinate with different stakeholders in supply chain and quality to initiate, execute, reconcile and close Product Hold Orders
  • Assist in the response to regulatory inquiries related to Field Corrective Actions
  • Ensure that the FCA plan follows all applicable internal, corporate and regulatory standards or requirements.
  • Maintain data and prepare reports, presentations, proposals and status updates for management.
  • Develops, implements, administers and certifies compliance policies, procedures, and practices. 
  • Ensures alignment with legal and ethical standards of the organization.
  • Develops, implements, administers and certifies compliance policies, procedures, and practices.

Must Have: Minimum Requirements
  • Bachelor's degree with 4+ years of quality, compliance, engineering or medical device experience OR Master's degree with 2+ years of quality, compliance, engineering or medical device 
Nice to Have
  • Project/Program management experience with ability of managing multiple projects simultaneously.
  • Advanced skill level for Excel, database and data analysis
  • Experience with inventory systems
  • Strong attention to detail
  • Experience developing effective written communications and executive presentations
  • Experience in customer service, supply chain, or  contracts
  • Demonstrate sound judgment and critical  thinking
  • Energetic individual with ability to work under pressure and with tight deadlines
  • Experience with FDA regulatory medical device requirements, 21CFR Part 806, Part 7; ISO 13485, Medical Device Directive.
  • General knowledge of Database Systems such as SAP, Siebel, Factory Works.

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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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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