Associate MDR/Vigilance Specialist Medtronic 2,450 reviews - Mounds View, MN Careers that Change Lives The Cardiac and Vascular Group brings all of our cardiac and vascular businesses together into one cross-functional, collaborative operating unit to employ the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. CARDIAC RHYTHM AND HEART FAILURE offers devices and therapies to treat abnormal heart rhythms, as well as cardiac diagnostic and monitoring solutions. A Day in the Life The Associate MDR/Vigilance Specialist participates in the company's medical device and/or drug surveillance platform; including the intake, evaluation, processing, and follow-up on product performance events, complaints, and adverse reports. The MDR Specialist analyzes events reported from multiple inputs on Cardiac Rhythm and Heart Failure Management (CRHF) products to determine complaint status and regulatory reportability. In addition, this position supports the ongoing monitoring of product performance. Works cross-functionally to ensure maintenance and review of events and complaints, reporting of Medical Device Reports (MDRs), ADE data, or adverse reaction data, as set forth by the FDA and other regulatory agencies. Requires follow-up internally and externally to assure complete and accurate event files, complaint detail, and product performance information. Supports and represents complaint handling in internal and external audits and inspections. As part of the Cardiac and Vascular Group Product Experience Management organization, we seek candidates who will meet our customer expectations by striving without reserve for the greatest possible reliability and quality in our products, processes and systems by being accountable, having a voice, and taking action. 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 REQUIRED EDUCATION: * Bachelors Degree REQUIRED YEARS OF EXPERIENCE: * 0+ years of experience in a health, clinical, technical, or scientific field with a Bachelors Degree Nice to Have * Attention to detail * Strong communication skills * Can work independently in a team environment * Takes initiative and proactively seeks quality solutions through continuous improvement * Knowledge of CRHF products and therapies * Experience in a clinical or regulated environment * Lean Sigma Experience (Green Belt/Black Belt) * Experience with complaint handling, MDR/Vigilance reporting * Knowledge of 21 CFR Part 820, Quality System Regulations * Knowledge of 21 CFR Part 803, Medical Device Reporting * Knowledge of 45 CFR Parts 160 and 164, The Privacy Rule, HIPAA * Effective priority setting * Solid knowledge of word processing, spreadsheet, database and presentation applications 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 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. 9 hours ago - save job - original job Apply On Company Site * Associate Mdr Vigilance Specialist jobs in Mounds View, MN * Jobs at Medtronic in Mounds View, MN * Associate Mdr Vigilance Specialist salaries in Mounds View, MN Medtronic Medtronic 2,450 reviews Founded in 1949 as a repair shop for medical devices, Medtronic has grown to become one of the largest healthcare technology companies in... Let employers find you Thousands of employers search for candidates on Indeed Upload Your Resume