Job Title:
Associate MDR & Vigilance Specialist
About the Role:
This exciting opportunity has arisen for an Associate MDR & Vigilance Specialist to join our dynamic team in Galway, Ireland. As a key member of our Complaint and Quality Management (CQXM) department, you will play a vital role in ensuring the highest standards of patient safety and customer satisfaction.
Main Responsibilities:
* Complaint Management: Coordinate the complaint handling process for medical devices, with a focus on pacemakers, including receipt, documentation, and investigation to determine root cause.
* Regulatory Reporting: Maintain accurate Medical Device Reports (MDRs) as required by global regulatory agencies and respond to queries from these agencies.
* Cross-Functional Collaboration: Work closely with teams in Galway and the US to drive successful outcomes through effective communication and teamwork.
* Risk Management: Support risk management processes, including risk analysis and health hazard assessments associated with complaints and post-market information.
* Continuous Improvement: Contribute to ongoing improvement initiatives within the CQXM department, helping to roll out cell operating systems and principles.
Requirements:
* Educational Background: Bachelor's degree (Level 8 NFQ) in Engineering, Science, Legal, Clinical, or a related discipline.
* Industry Experience: 1-2 years of experience in a medical devices or similar regulated environment.
* Critical Thinking: Ability to think critically, make sound decisions, and pay strong attention to detail.
* Technical Knowledge: Solid understanding of basic anatomy, physiology, and medical terminology.
* Communication Skills: Excellent communication skills, with fluency in English, both written and spoken.
* Customer Focus: Strong focus on patient safety and customer service, setting high standards for operational excellence.
About Us:
We are a leader in healthcare innovation, committed to making a difference in the medical devices industry. Our company culture is supportive, forward-thinking, and dedicated to growth and development.
Why Choose Galway?
Galway offers an exceptional quality of life, vibrant community, and rich cultural heritage, making it an ideal place to live and work. Set against the stunning backdrop of the Wild Atlantic Way, our city is a hub of creativity, innovation, and entrepreneurial spirit.