Associate MDR / Vigilance Specialist – 2 Year Contract
My client, a leading medical device manufacturer, is seeking an Associate MDR / Vigilance Specialist for their Galway site. The Successful candidate will be part of a high performing Complaint Handling and Medical Device Regulatory reporting department, which provides value throughout the Product Life cycle through world class execution in Medical Device Reporting and Vigilance compliance.
This will be a 2-year Contract position.
Working Hours (if applicable – Shift Etc)
Day Shift - Hybrid Working
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 analyse 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:
· Requires a level 8 degree in Mechanical/Biomedical Engineering / Science or related discipline
· 2 years of relevant experience.
· Requires broad theoretical job knowledge typically obtained through advanced education
If interested, please forward your most updated CV to [email protected]
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