MDR/Vigilance Specialist - Northridge, CA or Remote within US

MDR/Vigilance Specialist - Northridge, CA or Remote within US

Medtronic Cardiac and Vascular
2-5 years
Not Specified

Job Description

Careers That Change Lives
In this exciting role as a Medical Device Report/Vigilance Specialist you will have responsibility as an individual contributor with a medical professional background to support the time driven business needs to complete medical reviews of commercial complaints for severe adverse events, deaths, as well as review of Initial Impact Assessments for Risk Management and Risk Reviews (CAPAs). DIABETES
Our strategy is to become a holistic diabetes management company focused on making a real difference in outcomes and cost. We want to transform healthcare toward value-based models by driving both product and business model innovation with the goal of elevating patient experience, improving clinical outcomes and lowering the total cost of care for our customers.
We value what makes you unique. Be a part of a company that thinks differently to solve problems, make progress, and deliver meaningful innovations.
Visit to see an overview of the products in our Diabetes product portfolio.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
  • Provides medical expertise and assessment as it relates to device functionality and patient safety outcomes.
  • Applies technical and clinical knowledge regarding product usage and performance, specifically as it relates to patient safety and relationship of the reviewed severe adverse event or death to the device in use.
  • Applies knowledge of Medtronic Diabetes products and therapies, such as device design and function, product labeling, indications, mechanism of action, care pathways, and overall safety profile (i.e.hazards and harms) to assessment of medical review outcomes.
  • Leverages medical knowledge and advocate for patient safety by providing medical safety input to internal functions and business processes for new product assessments.
  • Escalates events and potential safety signals identified through complaint reviews to the office of Medical Affairs for additional assessment.
  • Collaborates with Office of Medical Affairs/Medical Safety, Risk Management, 24 Hr. HelpLine, Quality/Engineering and Failure Analysis to make accurate assessments of patient pump and device usage
  • 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.

Typically, an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects - from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.
Autonomy: Established and productive individual contributor.
Works independently with general supervision on larger, moderately complex projects / assignments.
Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments.
Contributes to the completion of project milestones .
May have some involvement in cross functional assignments.
Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex .
Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
Communication and Influence: Communicates primarily and frequently with internal contacts .
External interactions are less complex or problem solving in nature.
Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making.
Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.
Must Have: Minimum Requirements
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelor's degree in Nursing or Medical degree with 2+ years experience in medical safety/medical affairs, or Advanced degree with 0years experience in medical safety/medical affairs.
Nice to Have
  • Licensed healthcare professional or certified personnel with clinical knowledge and relevant patient care experience (e.g., RN, CDE, MD, PA, RD)
  • Medical background with the ability to understand complex disease states and different treatment outcomes
  • Medtronic Diabetes medical device experience highly preferred

Job Details

Employment Types:

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. Ability to travel up to 10% domestically as needed.

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