Assoc MDR Vigilance Specialist

PE Global; Galway; Hybrid; EUR 42,000 - 65,000; Full time

Benefits offered by this job

Hybrid work options

Job summary

PE Global is recruiting for an Associate MDR/Vigilance Specialist for our medical device client based in Galway. This is an initial 12-month contract role with hybrid working options.

The position involves receiving and coordinating product complaints, supporting adverse event reporting, maintaining MDRs, and contributing to regulatory reporting processes within the CQXM department. Strong documentation and cross-functional collaboration are essential.

Qualifications

• Bachelor’s degree at NFQ Level 8 or equivalent inEngineering/Science/Law/clinical field.
• 1-2 years of relevant experience in a medical device environment is desirable but not required.
• Strong attention to detail and accurate documentation.

Responsibilities

• Receive, document and coordinate incoming product complaints, ensuring records are accurate and complete.
• Coordinate cross-functional complaint investigations and support root cause determination.
• Support post-market surveillance activities, including evaluation and follow-up of adverse event reports.
• Maintain complete and accurate Medical Device Reports (MDRs) and safety reports in line with regulatory requirements.
• Support responses to regulatory agency queries relating to complaint events and post-market reports.
• Review and analyse complaint and safety data to support reporting and safety summaries.
• Contribute to risk management and health hazard assessments related to complaint and post-market information.
• Collaborate with internal stakeholders and external partners to support regulatory reporting processes.
• Contribute to continuous improvement initiatives within the CQXM department.
• Complete assigned tasks and project activities per company policies.

Skills

Attention to detail

Cross-functional collaboration

Documentation

English communication

Education

Bachelor’s degree (NFQ Level 8) in Engineering/Science/Law/clinical discipline

Job description

PE Global are recruiting for an Associate MDR/Vigilance Specialist for our medical device client based in Galway. This is an initial 12-month contract role. Hybrid working options.

Job Responsibilities

• Receive, document and coordinate incoming product complaints, ensuring records are accurate and complete.
• Coordinate cross-functional complaint investigations and support root cause determination.
• Support post-market surveillance activities, including the evaluation, processing and follow-up of adverse event reports.
• Maintain complete and accurate Medical Device Reports (MDRs) and other applicable safety reports in line with regulatory requirements.
• Support responses to regulatory agency queries relating to complaint events and post-market reports.
• Review and analyse complaint and safety data to support accurate reporting and high-quality safety summaries.
• Contribute to risk management, risk analysis and health hazard assessments associated with complaint and post-market information.
• Collaborate with internal stakeholders and external partners to support regulatory reporting processes.
• Contribute to continuous improvement initiatives, including the rollout of cell operating systems and principles within the CQXM department.
• Complete assigned tasks and project activities in accordance with company policies and procedures.

Education & Experience

• A bachelor's degree at NFQ Level 8, or equivalent, in Engineering, Science, Law, a clinical discipline or a related field.
• Previous experience in a medical device or related environment is desirable; 1-2 years of relevant experience is preferred, but not essential.
• Basic knowledge of anatomy, physiology and medical terminology.
• Strong attention to detail and a commitment to accurate documentation.
• Critical thinking, problem-solving and sound decision-making skills.
• A proactive, collaborative approach to working with cross-functional teams.
• Strong written and verbal communication skills, with fluency in English.
• A commitment to customer service, ethical conduct and accountability.

Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland