Associate MDR/Vigilance Specialist

Desired Skills: MS Office Suite,Medical Devices,Science,Engineering,Clinical,Law

The Role

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.

Interested candidates should submit an updated CV.

Please click the link below to apply, alternatively send an up-to-date CV aisling.oleary@peglobal.net

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