Cregg Recruitment are currently hiring a Associate MDR/Vigiliance Specialist to work in a large medical device in Galway for more information, call Stephen Coen 0861030418 Email stephencoen@cregg.ie

Responsibilities:
 

• 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.
• Review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries.
• Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.

Requirements:

• Qualified person to Bachelor’s degree (Level 8 NFQ) in Engineering/Science or related discipline.
• 2 years relevant experience 
• Dynamic team player, attention to detail, goal-orientated, good communicator and problem solving skill-sets
• Medical device experience desirable
• 100% desk based.