Associate MDR Vigilance Specialist

Location: Galway
Job Type: Contract
Duration: 12 months, with potential for extension
Hybrid

About the Role

We are seeking an Associate MDR Vigilance Specialist to join a leading medical device environment in Galway. This is an excellent opportunity for a science, engineering or clinical graduate to develop their expertise in medical device vigilance, complaint handling and post-market surveillance.

Working alongside experienced professionals and cross-functional teams, you will support the investigation of product complaints, regulatory reporting and safety monitoring activities, helping to ensure compliance with applicable regulatory requirements and maintain a strong focus on patient safety.

Key Responsibilities

• Receive, document and coordinate product complaints, ensuring records are accurate, complete and maintained to a high standard.

• Coordinate complaint investigations with cross-functional teams and support root cause analysis.

• Assist with post-market surveillance activities, including the assessment, processing and follow-up of adverse event reports.

• Prepare and maintain Medical Device Reports (MDRs) and other relevant safety documentation in line with regulatory requirements.

• Support responses to regulatory agency queries relating to product complaints and safety reports.

• Review and analyse complaint data to support accurate reporting and the preparation of safety summaries.

• Contribute to risk assessments, risk analysis and health hazard evaluations associated with product complaints.

• Liaise with internal stakeholders and external partners to support regulatory reporting processes.

• Participate in continuous improvement initiatives and departmental projects.

• Ensure all activities are completed in accordance with established procedures, quality standards and regulatory requirements.

Requirements

• A bachelor's degree at NFQ Level 8 or equivalent in Science, Engineering, Law, a clinical discipline or a related field.

• Previous experience in a medical device, pharmaceutical or other regulated environment is desirable.

• Approximately 1–2 years of relevant experience is advantageous, although candidates with limited experience will also be considered.

• A basic understanding of anatomy, physiology and medical terminology.

Key Skills

• Excellent attention to detail and strong documentation skills.

• Analytical thinking and problem-solving abilities.

• Strong written and verbal communication skills, with fluency in English.

• Ability to work collaboratively with cross-functional teams.

• A proactive approach to learning, accountability and continuous improvement.

• A strong commitment to quality, ethical standards and patient safety.

What's on Offer?

• A 12-month contract with the possibility of extension.

• An opportunity to gain valuable experience in medical device regulatory affairs and vigilance.

• Exposure to complaint investigations, post-market surveillance and regulatory reporting.

• The opportunity to develop specialist knowledge within a highly regulated industry.

Interested in this opportunity? Apply today to find out more about this contract role in Galway.
pbrowne@sigmar.ie