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Regulatory Affairs Specialist

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Regulatory Affairs
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20000BNZ Requisition #
Thanks for your interest in the Regulatory Affairs Specialist position. Unfortunately this position has been closed but you can search our 2,971 open jobs by clicking here.
Must Have Minimum Requirements:
  • BA and/or BS degree
  • Minimum of 2 years regulatory affairs or other relevant experience with Bachelors
  • Minimum of 0 year regulatory affairs and other relevant experience with an advanced degree 
Nice To Have
  • Degree in scientific or technical discipline
  • Masters in Regulatory Affairs
  • Experience with FDA requirements, guidance documents, Medical Device Directive, Medical Device Regulations, ISO 14971, ISO 13485, IEC 60601,  and other global regulatory requirements and quality standards 
  • History of successful device submissions
  • Strong negotiation skills and written/oral communication skills
  • Experience with cross-function project teams
  • Strong organizational skills and time management skills
  • Ability to multitask, support multiple projects, function on a global basis, prioritize, conduct team meetings, and meet project deadlines
  • Computer skills; MS Office, Adobe Acrobat
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Benefits
  • Vanpools from the San Francisco Bay Area including San Francisco and Oakland.
  • Summer Hours
  • Comprehensive medical coverage



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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