The RolePE Global are recruiting for anAssociate MDR/Vigilance Specialistfor our medical device client based in Galway. This is a 24-month contract role. Hybrid working options.Job ResponsibilitiesMonitors 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 & ExperienceBachelor'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 detailKnowledge of basic anatomy, physiology, and medical terminologyMust 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 speakingInterested 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****