Vigilance Specialist

Description:

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!

A Day in The Life Of:

Responsibilities may include the following and other 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 event reports, complying with government regulations.
• Evaluate incoming information to determine Medical Device Reporting and Vigilance reporting eligibility.
• Ensure complete, accurate, and timely submission of Medical Device Reports (MDRs) and Vigilance Reports (VR) as required by regulatory agencies.
• Interface and collaborate with internal and external contacts to ensure appropriate collection of complaint information in an efficient and customer focused manner.
• Maintain awareness of new products, government regulations and requirements.
• 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-Medical Engineering Science, Engineering or related discipline is preferred.
• Medical device industry experience is advantageous.
• Strong verbal and written communication skills
• Knowledge of basic anatomy and physiology
• Strong attention to detail
• High level of computer proficiency (Microsoft Office, SAP, Siebel, Oracle Clinical, etc.)