The Role
PE Global are recruiting for an
Associate MDR/Vigilance Specialist
for our medical device client based in Galway. This is a 24-month contract role. Hybrid working options.
Job 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.
Education & Experience
* Bachelor's degree (Level 8 NFQ) in Engineering/ Science/ Legal/ Clinical or related discipline.
* 1-2 years relevant experience in a medical devices or related environment preferred.
* Dynamic team player who can work effectively and proactively on cross functional teams.
* Ability to think critically and make sound decisions.
* Strong attention to detail
* Knowledge of basic anatomy, physiology, and medical terminology
* Must be focused on patient safety and customer service, set high standards, instil operational excellence, drive accountability and model ethical behaviour.
* Good communicator and fluent in English, both in writing and speaking
Interested candidates should submit an updated CV.
Please click the link below to apply, alternatively send an up-to-date CV
****Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland****