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Regulatory Labeling Specialist

Regulatory Affairs
2100075S Requisition #
Thanks for your interest in the Regulatory Labeling Specialist position. Unfortunately this position has been closed but you can search our 2,988 open jobs by clicking here.

Must Have: Minimum Requirements (Must be evident on the resume)

  • Bachelor's Degree required.  
  • Minimum 2 years of US/EU medical device regulatory or medical device quality experience 
  • Minimum 0 years of US/EU medical device regulatory experience with advanced degree 

Nice to Have

  • Masters in Regulatory Affairs
  • Knowledge of FDA and EU requirements
  • Willingness to learn and stay abreast of labeling regulations for medical devices
  • Ability to build relationships with other departments (i.e. Marketing, Packaging, Development)
  • Strong written and oral communication, teamwork, and organizational skills
  • 510(k) or PMA submission experience 
  • Degrees in Legal or Regulatory Affairs preferred
  • Knowledge of FDA and EU Labeling Regulations, includes promotional labeling requirements
  • Strong negotiation skills and written/oral communication skills
  • Strong technical writing skills
  • Strong organizational skills and time management skills

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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