QC Analyst

The Role

PE Global are recruiting for an Associate MDR/Vigilance Specialist for our medical device client based in Galway. This is a 23-month contract role. Hybrid working options.

• 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.
• The majority of time is spent delivering and overseeing the projects – from design to implementation – while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

Education & Experience

• 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

Interested candidates should submit an updated CV.

Please click the link below to apply, or alternatively send an up-to-date CV aisling.oleary@peglobal.net

****Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland****