MDR/Vigilance Specialist

Medtronic - Miami Lakes, FL

Full-time
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 as cardiac 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 complaint and reportability status. Complete applicable Medical Device Reports (MDR) and Vigilance Reports as required per internal policy & procedures and FDA/Worldwide regulations.
Disassociate applicable Adverse events (AE) with or without Malfunctions per regulatory guidelines (required to be performed by a qualified healthcare professional- RN or MD).
Ensure complaint investigations are adequate, accurate, detailed and timely.
Perform tasks to obtain adequate information to ensure proper documentation and closure of each complaint.
Collaborate with appropriate Technical, Clinical, Field/Sales and/or Returned Product analysis employees to determine reporting eligibility.
Complete electronic submission of regulatory reports to applicable regulatory agencies.
Proficient with internal systems, methods, and procedures to maintain compliance and support post-market surveillance. Evaluate and recommend changes to current systems.
Develop and demonstrate proficient knowledge of MCS products.
Assist in inspection support for FDA and global regulatory agencies. This may include research and preparation of correspondence in response to global regulatory agencies requests for additional information.
Maintain a working knowledge of regulations and standards related to post-market quality & complaint handling.
Identify and complete projects to advance post-market quality and complaint handling.
Support review and modification of department procedures as necessary to stay current with corporate standards and regulations.

Must Have: Minimum Requirements

Registered Nurse (RN) with Bachelor's degree or with Bachelors of Science in Nursing (BSN)-RN or Medical Degree, Cardiovascular Perfusionist with 2+ years of quality, clinical or regulatory experience

Nice to Have
Cardiac Background
Heart Failure
Complaint handling experience
Knowledge of CRHF products and therapies
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
Attention to detail
Strong communication skills
Can work independently in a team environment
Takes initiative and proactively seeks quality solutions through continuous improvement
Proficient in word processing, spreadsheet, database and 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. Let’s 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).