Associate MDR Vigilance Specialist

CareerWise Recruitment; Galway; Hybrid; EUR 42,000 - 56,000; Full time

Job summary

CareerWise Recruitment in Galway is seeking an Associate MDR Vigilance Specialist for a full-time, hybrid 24-month contract. You will coordinate complaint handling activities for medical device products and support regulatory reporting.

The role requires a Level 8 NFQ Bachelor’s degree in a relevant discipline, 1–2 years’ experience in a medical devices environment, strong attention to detail, and fluent English.

Qualifications

• Bachelor's degree (NFQ Level 8) 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.

Responsibilities

• Monitors the company's surveillance program including intake, protocol development, evaluation, processing, and follow-up on adverse reports and regulatory compliance.
• Ensures complete and accurate maintenance and reporting of MDRs and ADE data as required by regulatory agencies.
• Reviews clinical databases for ADE data extraction and integrates data for standardized, high-quality safety summaries.
• Acts as liaison with internal and external collaborators to meet regulatory reporting requirements.

Skills

MDR Vigilance

Cross-functional teamwork

Attention to detail

Education

Bachelor's degree (NFQ Level 8) in Engineering/Science/Legal/Clinical

Job description

Role

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.

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.

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.

Skills

Associate MDR Vigilance TPBN1_IJ

Company Background

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.