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1+ months

Sr MDR/Vigilance Specialist

Medtronic
Northridge, CA 91325
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Sr MDR/Vigilance Specialist

Location:

Northridge, California, United States

Requisition #:

220000GM

Post Date:

Feb 11, 2022


**Careers That Change Lives**


In this exciting role as a Sr Medical Device Report/Vigilance Specialist you will have responsibility as an individual contributor with a medical professional background to support the time driven business needs to complete medical reviews of commercial complaints for severe adverse events, deaths, as well as review of Initial Impact Assessments for Risk Management and Risk Reviews (CAPAs).


**DIABETES**


Transforming diabetes care together, for greater freedom and better health.


Our strategy is to become a holistic diabetes management company focused on making a real difference in outcomes and cost. We want to transform healthcare toward value-based models by driving both product and business model innovation with the goal of elevating patient experience, improving clinical outcomes and lowering the total cost of care for our customers.


We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.


Visit www.medtronicdiabetes.com to see an overview of the products in our Diabetes product portfolio.


**A Day in the Life**


Responsibilities may include the following and other duties may be assigned.


+ Monitors the companys drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations.

+ Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.

+ Review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries.

+ Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.


**Must Have: Minimum Requirements**


**To be considered for this role, please ensure the minimum requirements are evident on your resume.**


Bachelors Degreewith4+ years of work experience in a health, clinical, technical or scientific field OR Advanced Degree with 2+ years of work experience in a health, clinical, technical or scientific field


**Nice to Have**


Medtronic Diabetes medical device experience highly preferred


**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. Lets 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)


Ability to travel up to 10% domestically as needed.
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

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Posted: 2022-03-08 Expires: 2022-06-06
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Sr MDR/Vigilance Specialist

Medtronic
Northridge, CA 91325

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