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Associate Regulatory Affairs Specialist

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Regulatory Affairs
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19000APS Requisition #
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ASSOCIATE REGULATORY AFFAIRS SPECIALIST

 

Join us in our challenge to make global healthcare more affordable and accessible. Your insight and oversight will help us create solutions that change the world. These opportunities stretch across all Medtronic Business Units, Product Groups and Geographies. Those working within Regulatory Affairs have direct impact on Medtronic’s ability to provide leading edge medical solutions to people around the globe. 

 

Careers That Change Lives

 

The Associate Regulatory Affairs Specialist will assist with preparation of U.S. FDA submissions, Technical Files, reviewing design control documents and change requests, and being an active member of design teams representing the regulatory affairs responsibility. 

 

A Day in the Life

  • Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
  • Leads or compiles all materials required in submissions, license renewal and annual registrations.
  • Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
  • Monitors and improves tracking / control systems.
  • Keeps abreast of regulatory procedures and changes.
  • May direct interaction with regulatory agencies on defined matters.
  • Recommends strategies for earliest possible approvals of clinical trials applications.

Must Have; Minimum Requirements
  • Bachelors Degree 
  • 0 years of experience required 
Nice To Have
  • Bachelors Degree in health profession, science and/or engineering field
  • Masters Degree in Regulatory Affairs
  • RAC Certification
  • Two or more years experience with regulatory affairs in the medical device industry
  • Demonstrated experience in preparing 510(k) submissions for FDA, experience with Class III devices are a plus
  • Demonstrated experience with submission to the European Union
  • Demonstrated technical writing 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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