Cregg Recruitment | Mdr Vigilance Specialist Galway (Remote)

MDR Vigilance Specialist Galway (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 unique Remote working role offers great Work From Home flexibility and comes with great career progression opportunities to develop and further progress your career path.
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 andregulatory experience Requirements: Minimum of Degree Level 8 in Mechanical/Biomedical Engineering/ Science or related discipline.
1-2 years of relevant experience required.
Medical device/Pharma Documentation advantageous but not essential For more information on this excellent job opportunity get in touch with Gary Keane Call: Email: Skills: Quality Engineer CAPA Medical devices Complaints RCA NCR's