MDR/Vigilance Specialist

Medtronic Inc. Mounds View, MN
Careers that Change Lives

In this exciting role as a MDR/Vigilance Specialist you will have responsibilityfor analyzing customer complaints todetermine which are regulatory reportable, will generate and submit theregulatory reports within the government mandated timelines, and is a key contact for activitieswith internal, field, and end user customers.

The Cardiac and Vascular Group brings all of our cardiac andvascular businesses together into one cross-functional, collaborative operatingunit to employ the full breadth of our talent, technologies, products,services, and solutions to address the needs of customers and patients acrossthe globe.

CORONARY AND STRUCTURAL HEART provides interventionaldevices to treat coronary arteries that are blocked by atherosclerotic plaqueand devices and therapies to treat structural defects of the heart.

A Day in the Life

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

* Facilitates complaint communications and assess for regulatoryreportability and potential impact to patient safety and business operations.

* Completes and submits regulatory reports within the requiredtimeframes.

* Evaluates identified complaints. Investigate complaints by gatheringsufficient data from clinical staff, Medtronic field representatives, internalemployees, and laboratory analysis.

* Develop internal systems, methods, and procedures to maintaincompliance and support post-market surveillance. Evaluate and recommend changes to currentsystems. Serve on multi-business teamsto evaluate system changes/upgrades.

* Receive and document product events reported by customers andfield representatives. Requestadditional information as needed for complete understanding of the event. Determine if event is a productcomplaint.

* Enter all information related to the events into thecomplaint database. Maintain files thatmeet the QSR and Corporate requirements.

* Maintain technical knowledge of devices in area ofresponsibility.

* Review and modify department procedures as necessary to staycurrent with corporate standards.

* Routinely analyze and evaluate work processes to improve workprocesses and service to customers.

* Solid knowledge and experience to generate and approvestandard changes related to the individual's area.

Must Have: Minimum Requirements

REQUIREDEDUCATION:

* Bachelor's Degree

REQUIREDYEARS OF EXPERIENCE:

* 2+years (with Bachelor's) or less than one year (with Master's) of experience ina health, clinical, technical or scientific field

Nice to Have

* Solid understanding and application of business concepts andpractices.

* Solid knowledge in clinical settings related to productapplication.

* Clinical and/or regulatory background.

* Multi-taskmanagement

* Effectivepriority setting

* Solidknowledge of word processing, spreadsheet, database and graphics presentationapplications.

* Solidoral and written communication skills

* Recordmanagement

* Exercisesjudgment in selecting innovative, practical methods to achieve problemresolution.

* Worksunder minimal supervision.

* Establishesand cultivates an extensive network of support to facilitate completion ofassignments.

* RN, CNP, JD, or BioMedical Engineer

* 4+ years of related work experience

* Solidknowledge of worldwide adverse event reporting requirements (21 CFR 803, QSR820, MEDDEV 2.12-1, Article 253 of Pharmaceutical Affairs Law, etc.).

* Cath lab and/or OR experience

* ASQ Certified Engineer

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.