Associate MDR Vigilance Specialist

Posted 24 April 2024
Salary €37,000 - 45,000 per month
LocationGalway
Job type Temporary
Discipline Medical Devices
ReferenceLFHAMDR0424
Contact NameLauryn Flanagan Higgins

Job description

About Your New Employer

You will work for a global medical device company, based on their site in Galway.

You will work as an Associate MDR and Vigilance Specialist and have a background in quality administration or document control and have a knowledge of regulatory requirements for the medical device industry.  

Please note that this is a 100% desk based job.

About Your New Job   

As an Associate MDR and Vigilance Specialist you will…

  • 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.

What Skills You Need

  • Bachelor’s degree (Level 8 NFQ) in Engineering/Science or related discipline.
  • 2 years relevant experience 
  • Medical device experience desirable

What’s on Offer

  • 23 month contract
  • Hybrid Model – 3 days on site, 2 days working from home

What’s Next

Apply now by clicking the “Apply Now" button or call me Lauryn Flanagan on +353 91 455306

Or if the job isn’t quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC and Contract jobs available.