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Regulatory Affairs Specialist - US -Neurosurgical

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Regulatory Affairs
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1900006R Requisition #
Thanks for your interest in the Regulatory Affairs Specialist - US -Neurosurgical position. Unfortunately this position has been closed but you can search our 1,536 open jobs by clicking here.

MINIMUM REQUIRED QUALIFICATIONS (MUST BE EVIDENT ON YOUR RESUME):

• Bachelor's Degree
• 2+ years of medical device experience, with work experience in regulatory affairs with Bachelor’s degree.
• 6+ months of medical device experience, with Master’s degree.

DESIRED/PREFERRED QUALIFICATIONS:
• History of successful 510(k)/PMA device submissions  
• Experience with FDA requirements, guidance documents, Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards
• Excellent analytical thinking skills
• Ability to effectively manage multiple projects and priorities
• Proven ability to work effectively in cross-functional teams
• Excellent written and verbal communications skills
• Strong organization and time management skills
• Demonstrated ability to influence based on experience, facts and data
• Highly motivated and results-oriented leader
• Project-management skills
• Presentation skills for small to mid-sized groups
• Detail-oriented
• Ability to be flexible with changing priorities
• Submission-related word processing skills
 
PHYSICAL 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.
• 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.
• Must be able to travel independently to various Medtronic buildings/sites.
• Must be able to travel by plane and by car.(<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.
 
BRAIN THERAPIES included Neurosurgery Products to offer an integrated portfolio of devices and therapies for the treatment of neurological disorders and diseases, as well as surgical technologies designed to improve the precision and workflow of neuro procedures.
 
This is a 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
 
Whatever your specialty or ambitions, you can make a difference at Medtronic – both in the lives of others and your career.
 
Medtronic is a $29.7b company with 90,000+ employees in more than 160 countries.
 
ABOUT MEDTRONIC:
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.

EEO STATEMENT:
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

DISCLAIMER:
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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