Complaint Handling Specialist

We are seeking a detail-oriented and motivated Complaint Handling Specialist to join a Quality team in Galway.

 In this role, you will play a key part in ensuring product quality, regulatory compliance, and, most importantly, patient safety. Working within a highly regulated environment, you will investigate product complaints, coordinate cross-functional investigations, and support post-market surveillance activities.

This is an excellent opportunity for someone looking to develop their career within the medical device or life sciences industry while making a meaningful impact on healthcare outcomes.

Key Responsibilities

• Coordinate complaint handling activities across a diverse portfolio of medical products.
• Receive, document, and assess incoming product complaints accurately and within required timelines.
• Lead and coordinate cross-functional investigations to identify root causes of complaints.
• Maintain accurate complaint records and prepare Medical Device Reports (MDRs) in accordance with regulatory requirements.
• Support responses to regulatory authority requests relating to complaints and post-market surveillance.
• Contribute to risk management activities, including risk analysis and health hazard assessments based on complaint data.
• Participate in continuous improvement initiatives to enhance complaint handling processes and operational excellence.
• Collaborate effectively with Quality, Regulatory Affairs, Manufacturing, Engineering, and other cross-functional teams.

Skills & Experience

• Bachelor’s degree in engineering, Science, Clinical Studies, Legal Studies, or a related discipline.
• 1–2 years' experience within the medical device, pharmaceutical, or another regulated industry is essential
• Strong analytical and critical thinking skills with sound decision-making abilities.
• Excellent attention to detail and organisational skills.
• Strong teamwork and communication skills with the ability to collaborate across multiple functions.
• Excellent written and verbal communication skills in English.
• A strong commitment to patient safety, customer service, quality, and ethical conduct.

For more information or to apply, please send your CV to sarah.kelly@cpl.ie or contact Sarah Jeanne on 061 208649