Our client a leading multinational based in Galway, is currently hiring multiple Associate MDR Vigilance Specialists on 23-month contracts.
This is a hybrid role – 2 days per week in the office.
The Role:
As an Associate MDR Vigilance Specialist, you will play a vital role in supporting the company’s drug and medical device surveillance programs.
Your primary responsibilities will include:
Monitoring surveillance activities, including intake, protocol development, evaluation, processing, and follow-up on adverse event reports.
Participating in activities to resolve potential legal liability and ensuring compliance with applicable regulatory requirements.
Ensuring accurate maintenance and timely reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data, or other adverse event data to regulatory agencies.
Reviewing and analyzing clinical databases to extract ADE data, integrating findings to support standardized and high-quality safety summaries.
Collaborating internally and externally to develop effective programs and processes that meet evolving regulatory reporting standards.
Requirements:
Bachelor’s degree (Level 8 NFQ) in Engineering, Science, Legal, Clinical, or a related discipline.
1–2 years of relevant experience in the medical device industry or a related regulated environment is preferred.
Strong critical thinking and decision-making abilities.
Excellent attention to detail.
Knowledge of basic anatomy, physiology, and medical terminology.
Committed to patient safety and customer service.
Ability to work proactively and effectively within cross-functional teams.
Strong communication skills; fluent in English (both written and spoken).
For more information and a confidential discussion on the role please contact Michelle Mc Inerney.
michelle.mcinerney@collinsmcnicholas.ie
091 706717