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Regulatory Operations Specialist

Regulatory Affairs
19000E6Y Requisition #
Thanks for your interest in the Regulatory Operations Specialist position. Unfortunately this position has been closed but you can search our 2,213 open jobs by clicking here.
Must Have: Minimum Requirements (Must be evident on the resume)
• Bachelor's Degree
• 2+ years of experience in regulatory affairs, either in a regulatory products specialist role or regulatory operations role
Preferred Qualifications:
• Experience Records and data management
• Experience with Agile PLM
• Strong ability with MS Excel
• High attention to detail
• Highly skilled in task management
• Competent with MS Office (Word, Excel, PowerPoint, Visio, SharePoint, Access)
• Working knowledge of SAP, Agile, or related system
• Strong written/oral communication skills
• Strong organizational skills and time management skills
• Highly self-motivated
• Experience in the medical device industry in Quality or Regulatory
• Team player who seeks to help and learn from colleagues seeing the department success as their own
• A problem solver and critical thinker that relies on own judgment for appropriate level of decision making
• Ability to manage small scale projects to completion within and outside
• Previous experience supporting manufacturing and design changes a plus
• Experience with Class III devices are a plus

Physical Requirements:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 
The physical demands described within the Position 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. 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).  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• The employee is required to be independently mobile
• The employee must be able to travel independently to various Medtronic buildings/sites.
• The employee is required to interact with a computer, and communicate with co-workers
• The employee is required to travel by car and by airplane (<10%)
RTG (Restorative Therapies Group) Overview

The Restorative Therapies Group (RTG) develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.
Medtronic Neurovascular is focused on creating life-saving devices to treat stroke. As part of the Brain Therapies Organization, we are revolutionizing how acute ischemic and hemorrhagic stroke is treated all over the world. We are focused on meeting our goal of no patient lost, no patient delayed, best patient outcome.
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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 can 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.

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: http://www.uscis.gov/e-verify/employees

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
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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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