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Senior Regulatory Affairs Specialist

Regulatory Affairs
20000AM5 Requisition #
Thanks for your interest in the Senior 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

  • Bachelor’s degree in a technical discipline
  • Minimum 4 years of experience in regulatory affairs or the medical device industry with Bachelor’s degree   
  • Minimum 2 years of experience in regulatory affairs, or the medical device industry with an advanced degree

Nice To Have 

  • Master's in Regulatory Affairs
  • Experience working in regulated, biotechnology environment, including involvement with regulatory submissions, interactions with regulatory agencies (e.g., FDA and BSI), and working with cross-functional project teams.    
  • In depth experience with FDA requirements, guidance documents, Active Medical Device Directive, ISO 14971, ISO 13485, and other global regulatory requirements and quality standards 
  • Experience with Class II medical devices (PMA)
  • History of successful device submissions
  • Strong negotiation skills and written/oral communication skills
  • 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
  • Ability to work independently and under general direction only 
  • Computer skills; MS Office, MS Project, Adobe Acrobat and Agile

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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