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Principal Clinical Quality Systems Specialist

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Clinical
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19000F4L Requisition #
Thanks for your interest in the Principal Clinical Quality Systems Specialist position. Unfortunately this position has been closed but you can search our 1,863 open jobs by clicking here.

Must Have: Minimum Requirements

To be considered for this role, the minimum requirements must be evident on your resume. 

  • Bachelor’s degree with a minimum of 7 years of experience supporting clinical research/quality audits/compliance within the healthcare industry or advanced degree with a minimum of 5 years of experience supporting clinical research/quality audits/compliance within the healthcare industry
Nice to Have:    
  • Clinical Research / Quality audit / Quality system experience at Medtronic or within the medical device industry.
  • Knowledge and experience with FDA and international regulations (e.g., 21 CFR 812, 11, 50, 54, 56, 803, 806, 820, ISO 13485, ISO 14155) and/or experience in Quality System regulations.
  • Knowledge and/or experience in non-traditional clinical evidence generation
  • Experience in Good Clinical Practice (GCP) and/or regulatory compliance guidelines for clinical trials
  • Significant knowledge of clinical and outcomes research study design
  • Ability to incorporate and adhere to good clinical practices and regulatory standards
  • Database validation
  • Proficient knowledge of medical terminology.
 

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 above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

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)

 

Travel is required up to 25%.


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