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Regulatory Affairs
20000BIB Requisition #
Thanks for your interest in the Sr Regulatory Affairs Specialist - Globalization position. Unfortunately this position has been closed but you can search our 3,077 open jobs by clicking here.

Must Have: Minimum Requirements
Bachelor’s degree with 4+ years of experience in regulatory affairs and/or the medical device industry OR Advanced degree with 2+ years of experience in regulatory affairs and/or the medical device industry.


Nice To Have:

  • 5+ years medical device industry experience

  • Experience with Class II/III medical devices

  • Experience with medical device global product registrations/ submissions: US FDA 510(k)s/ PMAs, EU Tech Files, Health Canada license applications, Shonin (Japan PMDA), China NMPA, APAC and Latin America submissions.

  • Experience performing advertising and promotion reviews for medical devices

  • Medtronic product development experience

  • Clinical or statistical experience

  • Experience with international regulatory agency requirements, harmonized IEC/ISO/ GHTF standards.

  • Strong communication and project management skills

  • Effective interpersonal skills to be a good team member and mentor

  • Ability to comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills.

  • Ability to effectively manage multiple projects and priorities.

  • Proficient computer 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)

Travel up to 20% domestic & international

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