Associate MDR/Vigilance Specialist

Medtronic Inc. Portsmouth, NH
Careers that Change Lives

Your dedication is important to our customers and, most importantly, to their patients.

Medtronic is currently seeking an Associate MDR/Vigilance Specialist.

In this role you will participate in the company's medical device surveillance platform; including the intake, evaluation, processing, and follow up on product performance events, complaints, and adverse reports, specifically for the Transformative Solutions products.

Do meaningful work, make a difference, and improve lives — starting with your own.

The Restorative Therapies Group develops life-restoring therapies and healthcare solutions that span the care continuum; integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiency of procedures and deliver successful patient outcomes.

A Day in the Life

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

* Monitors the company's 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

Bachelor's degree in a Scientific or technical field with experience in a health, clinical, technical, or scientific field

Nice to Have

* Knowledge of Medtronic products and therapies

* Experience in a clinical or regulated environment

* Experience in complaint handling, MDR/Vigilance reporting

* Lean Sigma experience

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 above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Day in the Life 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.