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Associate MDR/Vigilance Specialist

Medtronic Cardiac and Vascular
0-3 years
Not Specified

Job Description

Careers That Change Lives
In this exciting role as an Associate MDR/Vigilance Specialist, you will have the responsibility and authority to document and evaluate product feedback and product analysis results for Medtronic Cardiovascular products to determine complaint status and regulatory reporting status in conjunction with US and OUS regulatory guidelines. In conjunction with US and OUS regulatory reporting criteria, the Associate MDR/Vigilance Specialist compiles regulatory agency reports for submission. As part of complaint closure activities this individual performs activities to monitor complaint activity to ensure timely review of product feedback, product analysis, product formal investigation, and any associated follow-up actions that pertain to complaint closure.
Cardiovascular Portfolio
The Cardiovascular portfolio brings all of our cardiac and vascular businesses together into one cross-functional, collaborative group to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe.
This groupoffers devices and therapies to treat abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions.
A Day in the Life
Responsibilities include the following but not limited to:
  • Apply policies and procedures to comply with FDA and OUS regulations.
  • Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse event reports, complying with government regulations.
  • Evaluate incoming information to determine Medical Device Reporting and Vigilance reporting eligibility.
  • Ensures complete, accurate, and timely submission of Medical Device Reports (MDRs), Vigilance Reports (VR) Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.
  • Interface and collaborate with internal and external contacts to ensure appropriate collection of complaint information in an efficient and customer focused manner.
  • Maintain awareness of new products, government regulations and requirements.
  • Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements
  • Other duties as assigned.

Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelor's Degree with 0 years of work experience
Nice to Have
  • Degree in Health Care, Sciences, or Bio-Medical Engineering
  • Medical device industry experience
  • Strong verbal and written communication skills
  • Knowledge of basic anatomy and physiology
  • Strong attention to detail
  • High level of computer proficiency

Job Details

Employment Types:

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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