MDR Vigilance Specialist – Galway (Hybrid / Remote)

MDR Vigilance Specialist – Galway (Hybrid / Remote)
 

MDR Vigilance Specialist – Galway
This is a Fantastic Opportunity to join a leading Medical Device company in Galway as an MDR Vigilance Specialist.
This Hybrid/Remote working role offers great Work From Home flexibility and comes with great career progression opportunities. 

Key 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.
• Ability to think critically and make sound decisions
• Strong attention to detail
• Technical, clinical and regulatory experience

Requirements:

• Minimum of Degree Level 8 in Mechanical/Biomedical Engineering/ Science or related discipline.
• 1-2 years of relevant industry experience required.

For more information on this excellent job opportunity get in touch with -: Gary Keane
Call: 061-363318
Email: garykeane@cregg.ie