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Assoc Regulatory Affairs Spec

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Regulatory Affairs
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190005AD Requisition #
Thanks for your interest in the Assoc Regulatory Affairs Spec position. Unfortunately this position has been closed but you can search our 2,086 open jobs by clicking here.

Minimum Education        Bachelor Degree


Basic Qualifications        

Background


Educational: Science, Engineering, Business Administration or related field


Experience:

Associate or Level 1:       0 Years with Diploma/ Degree


•             Exposure to compliance, configuration, documentation, quality systems, quality engineering, auditing, laboratory or regulatory manufacturing environment


Skills

•             Interpersonal Relations

•             Quality and Results Oriented

•             Computer Literate

•             Fluency speaking and writing in English and Spanish

 
Desired/ Preferred
Qualifications     Background

•             Experience in medical device, pharmaceutical, or electronic industry

•             Experience in Qualification / Validation activities.

•             Experience and Certification in Auditing

Skills
  • Problem Solving
  • Teamwork
  • Communications
  • Continues Improvement
  • Project Management
  • Root Cause Analysis
  • Technical Writing and Composition
  • US Class I, II and III manufacturing process change Regulatory Impact Assessment  Experience
  • OUS Impact assessment to notify manufacturing process changes
  • FDA 510 (k) Class II and PMA Class III Internal documentation report requirements knowledge 
Working Conditions        

Mental Components:

Capacity to calculate, classify, compare, coordinate, copy, edit, evaluate, interview, instruct, read, observe, organize, plan, compile, select, request and document.


Physical Components:

Light work requiring physical effort, in addition, requires communication skills, capability to move from one place to another, visual discrimination and tolerance to the use of personal protection equipment.


Environmental

Work is performed in building’s interior with normal temperature, good illumination, air condition, clean environment and minimum risk




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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Change Begins With You

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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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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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