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Regulatory Affairs Operations Specialist - Diabetes

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Regulatory Affairs
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1900001U Requisition #
Thanks for your interest in the Regulatory Affairs Operations Specialist - Diabetes position. Unfortunately this position has been closed but you can search our 1,668 open jobs by clicking here.

Must Have; Minimum Requirements:

Nice to Have:

  • Bachelor’s degree in Regulatory or related field
  • Experience in Regulatory, Operations and/or Quality
  • Project/program management experience
  • Knowledgeable of Medical Device Reporting (MDR) process and interested in becoming Regulatory Affairs Certified (RAC) to better assist department needs
  • Proficiency in an Enterprise Reporting System (ERP), such as SAP.
  • Knowledge of Diabetes products
  • General knowledge of medical terminology
  • Demonstrated proficiency using MS Office applications (i.e. Outlook, email, Excel, Word, and PowerPoint)
  • Knowledge of applicable US regulations, including 21 CFR Part 820 and 803 and HIPAA
  • Knowledge of international medical device regulations
  • Degree or course work in Regulatory Compliance and/or Quality Assurance a plus
  • Quality focused with strong organizational skills
  • Excellent reading comprehension in English
  • Must be detail-oriented, accurate and organized while handling multiple tasks
  • Excellent interpersonal and communication skills
  • Ability to work productively and positively with team members and cross-functionally in a large organization
  • Must be able to work flexible hours that may include working occasional weekends or evenings


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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