Quality & Regulatory Affairs Associate - Hybrid

Quality & Regulatory Affairs Associate - Hybrid

Medical Device - Galway

Role Overview

We are seeking a motivated Quality, Complaints & Regulatory Affairs Associate to join our growing medical device team in Galway. This is an excellent opportunity for a recent graduate (Level 8 qualification) or a candidate with 1+ year of relevant industry experience to develop their career within a regulated medical device environment.

The successful candidate will support quality system vigilance (EU MDR), complaint handling activities, and regulatory compliance to ensure products meet applicable regulatory and customer requirements.

Key Responsibilities

• Support maintenance and continuous improvement of the Quality Management System (QMS) in compliance with ISO 13485 and applicable regulations.
• Assist with internal audits and external audit preparation.
• Support CAPA (Corrective and Preventive Actions) activities.
• Participate in risk management activities in line with ISO 14971.
• Assist in document control and change management processes.
• Manage and investigate customer complaints in accordance with internal procedures and regulatory requirements.
• Perform root cause analysis and coordinate cross-functional investigations.
• Ensure timely complaint closure and appropriate documentation.
• Support trend analysis and complaint reporting metrics.
• Assist in vigilance reporting where required.
• Assist with technical documentation updates.
• Maintain product regulatory compliance records.

Qualifications & Experience

• Bachelor's Degree (Level 8) in Engineering, Science, Biomedical, Quality, or related discipline (essential).
• Graduate level or 1+ year experience in a regulated industry (medical device experience desirable).
• Knowledge of ISO 13485, EU MDR, and complaint handling processes is advantageous.
• Strong analytical and problem solving skills.
• Excellent written and verbal communication skills.
• High attention to detail and strong organisational skills.
• Ability to work both independently and within cross functional teams.
• Strong documentation and technical writing ability.
• Regulatory awareness and compliance mindset.
• EU MDR knowledge.
• Root cause analysis skills.