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Regulatory Affairs
20000CUU Requisition #
Thanks for your interest in the Senior Regulatory Affairs Specialist - Robotics position. Unfortunately this position has been closed but you can search our 1,666 open jobs by clicking here.

Must Have: Minimum Requirements

  • Bachelor’s Degree in scientific discipline
  • Minimum 4 years medical device regulatory experience 
  • Or an advanced degree with at least 2 years in a regulatory role for medical devices

Nice to Have 

  • Advanced Degree
  • RAC certification(s)
  • Regulatory experience involving electromechanical (including software) devices.
  • US Class II and EU Class IIb device experience and in-depth knowledge of US FDA regulations (Title 21) and EU CE Marking directives.
  • History of successful US 510(k) submissions, Q-submissions, EU technical files
  • In-depth knowledge of preclinical and clinical study rules/regulations.
  • Excellent written/oral communication skills.
  • Thorough knowledge of other regulations pertaining to the commercialization of medical devices.
  • Thorough/Working knowledge of MDSAP and EU. Specifically,
    • US Quality System Regulation, Canadian Medical Device Regulation, EU Medical Device Directive or Regulation (EU) 2017/745, and ISO 13485:2016.
  • Experience with US Class III device submissions, including IDE
  • Experience with SiMD and SaMD, including AI and Machine Learning
  • Regulatory Compliance competency (Inspections, Audits, Field Actions)
  • International Regulatory submissions experience
  • Clinical Trial experience, including IDE submissions

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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