Associate MDR / Vigilance Specialist
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first - developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
A Day in the Life
At our Customer Quality and Experience Management (CQXM) group, which is part of the Galway CQXM Complaint Handling and Regulatory Reporting Department in Medtronic plc, we focus on complaint handling and post market regulatory reporting activities for a wide range of Medtronic products. You will be part of a high performing Complaint Handling and Medical Device Regulatory reporting department, which provides value throughout the Product Life cycle through world class execution in Medical Device Reporting and Vigilance compliance.In this exciting role as an Associate MDR/Vigilance Specialist, you will have the responsibility and authority to document and evaluate product feedback and product analysis results for Medtronic products to determine complaint status and regulatory reporting status in conjunction with US and OUS regulatory guidelines. In conjunction with US and OUS regulatory reporting criteria, the Associate MDR/Vigilance Specialist compiles regulatory agency reports for submission.
As part of complaint closure this individual performs activities to ensure timely review of product feedback, product analysis, product formal investigation, and any associated follow-up actions that pertain to complaint closure.
Come for a job, stay for a career!
Responsibilities may include the following andother duties may be assigned.
Apply policies and procedures to comply with FDA and OUS regulations.
Monitor the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse eventreports, complyingwith government regulations.
Evaluate incoming informationto determine MedicalDevice Reporting and Vigilance reporting eligibility.
Ensurecomplete, accurate,and timely submissionof Medical Device Reports(MDRs) and VigilanceReports (VR) as required by regulatory agencies.
Interface and collaborate with internal and external contacts toensure appropriatecollection of complaint information in an efficient and customerfocused manner.
Maintain awareness of new products,government regulations andrequirements.
Act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.
Other duties as assigned.
Key Skills & Experience
Bachelors / Level 8 Degree with a minimum of 0 years experience.
1+ years of experience in MDR role is preferred
Degree in in Health Care, Sciences, or Bio-MedicalEngineering Science, Engineering or related discipline is preferred.
Medical device industry experience is advantageous.
Strong verbal and written communication skills
Knowledge of basic anatomy andphysiology
Strong attention to detail
High level ofcomputer proficiency (MicrosoftOffice, SAP, Siebel, Oracle Clinical, etc.)
Medtronic offer a competitive salary and flexible Benefits Package
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.
Recruitment Fraud Alert
We are aware of phishing scams targeting job seekers. Please keep the following in mind:
Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.
Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.
If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.
If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [email protected].
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create.We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Pay range / Rango salarial / Intervalo salarial /Fascia retributiva / Tranche de salaire / Gehaltsband / Salaribereik: Ireland: 40,000.00 EUR - 60,000.00 EUR | This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).