Associate MDR Vigilance Specialist

An Associate MDR Vigilance Specialist is required by CareerWise Recruitment for our multinational medical device client in Galway for a fulltime, hybrid role on an initial 24-month contract.

The Associate MDR Vigilance Specialist will be responsible for the co-ordination of complaint handling activities for a wide range of medical device products.

THE ROLE:

• 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.

REQUIREMENTS:

• Bachelor'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.
• Strong attention to detail
• Good communicator and fluent in English, both in writing and speaking.

Please call Laura Gallagher today for further information on 087- 4526468 or email: lgallagher@careerwise.ie

CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

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