26 days old

MDR/Vigilance Specialist

Miami Lakes, FL 33016
MDR/Vigilance Specialist


Miami Lakes, Florida, United States

Requisition #:


Post Date:

Nov 14, 2019

**Careers that Change Lives**

Together, we can change healthcare
worldwide. At Medtronic, we push the limits of what technology 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.

In this role, you will be a key
member of the Product Experience Management (PXM) team, which focuses on
complaint handling for the Mechanical Circularity Support (MCS) product line
within Cardiac and Vascular Group.

You will be responsible for
participating 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/Vigilance
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. This role also 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. This position will also focus on adverse
event disassociation which can only be performed by a qualified health care
professional (RN or MD).

This role will be expected to work
on occasion outside of normal business hours to meet the needs of global
business partners.

The Cardiac and Vascular Group
brings all 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 congested heart
failure, as well ascardiac diagnostic and monitoring solutions.

**A Day in the Life**

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

+ Electronically process events to determine complaintand reportability status. Complete applicable Medical Device Reports (MDR)and Vigilance Reports as required per internal policy procedures andFDA/Worldwide regulations.

+ Disassociate applicable Adverse events (AE) with orwithout Malfunctions per regulatory guidelines (required to be performedby a qualified healthcare professional- RN or MD).

+ Ensure complaint investigations are adequate, accurate,detailed and timely.

+ Perform tasks to obtain adequate information to ensureproper documentation and closure of each complaint.

+ Collaborate with appropriate Technical, Clinical,Field/Sales and/or Returned Product analysis employees to determinereporting eligibility.

+ Complete electronic submission of regulatory reports toapplicable regulatory agencies.

+ Proficient with internal systems, methods, andprocedures to maintain compliance and support post-market surveillance.Evaluate and recommend changes to current systems.

+ Develop and demonstrate proficient knowledge of MCSproducts.

+ Assist in inspection support for FDA and globalregulatory agencies. This may include research and preparation ofcorrespondence in response to global regulatory agencies requests foradditional information.

+ Maintain a working knowledge of regulations andstandards related to post-market quality complaint handling.

+ Identify and complete projects to advance post-marketquality and complaint handling.

+ Support review and modification of departmentprocedures as necessary to stay current with corporate standards andregulations.

**Must Have: Minimum Requirements**

Bachelor's degree
with Registered Nurse (RN) OR Bachelors of Science in Nursing (RN-BSN) OR
Medical Degree OR Cardiovascular Perfusionist with Bachelors degreeand2+ years of clinical experience

**Nice to Have**

+ Cardiac Background

+ Heart Failure

+ Complaint handlingexperience

+ Knowledge of CRHF products and therapies

+ Lean Sigma Experience (Green Belt/Black Belt)

+ Experience with complaint handling, MDR/Vigilancereporting

+ Knowledge of 21 CFR Part 820, Quality SystemRegulations

+ Knowledge of 21 CFR Part 803, Medical Device Reporting

+ Knowledge of 45 CFR Parts 160 and 164, The PrivacyRule, HIPAA

+ Attention to detail

+ Strong communication skills

+ Can work independently in a team environment

+ Takes initiative and proactively seeks qualitysolutions through continuous improvement

+ Proficient in word processing, spreadsheet, databaseand presentation applications

+ Effective priority setting

+ Experience working with customers

**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).
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.


Posted: 2019-11-19 Expires: 2019-12-26

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MDR/Vigilance Specialist

Miami Lakes, FL 33016

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