Associate MDR/Vigilance Specialist

PE Global (UK); Galway; On-site; EUR 45,000 - 60,000; Full time

Job summary

A medical device company in Galway is hiring an Associate MDR/Vigilance Specialist for a 12-month contract. The role involves monitoring medical device surveillance programs, ensuring accurate reporting of adverse events, and liaising with stakeholders to comply with regulatory requirements. Ideal candidates will have a bachelor's degree and relevant experience in medical devices, have strong communication skills, and are committed to patient safety. Hybrid working options are available.

Qualifications

• 1-2 years relevant experience in a medical devices or related environment preferred.
• Good communicator, fluent in English, both written and spoken.
• Knowledge of patient safety and operational excellence.

Responsibilities

• Monitor the company's drug or medical device surveillance program.
• Ensure accurate maintenance and reporting of Medical Device Reports.
• Review and analyze clinical databases for ADE data extraction.
• Liaise with internal and external collaborators for regulatory compliance.

Skills

Dynamic team player

Critical thinking

Attention to detail

Communication

Knowledge of anatomy and physiology

Customer service focus

Education

Bachelor's degree in Engineering/Science/Legal/Clinical or related discipline

Job description

The Role

PE Global are recruiting for an Associate MDR/Vigilance Specialist for our medical device client based in Galway. This is a 12-month contract role. Hybrid working options.

Job Responsibilities

• Monitors the company’s drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow-up on adverse reports, participation in the resolution of any legal liability and in complying with government regulations.
• Ensures complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies.
• Review and analyze clinical databases for the extraction of ADE data and integrates the data to ensure the creation of a unified database consistent with the aims and purposes of ADE standardization and internalization as well as to ensure the accuracy and quality of safety summaries.
• Acts as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.

Education & Experience

• Bachelor’s degree (Level 8 NFQ) in Engineering/ Science/ Legal/ Clinical or related discipline.
• 1-2 years relevant experience in a medical devices or related environment preferred.
• Dynamic team player who can work effectively and proactively on cross functional teams.
• Ability to think critically and make sound decisions.
• Strong attention to detail
• Knowledge of basic anatomy, physiology, and medical terminology
• Must be focused on patient safety and customer service, set high standards, instil operational excellence, drive accountability and model ethical behaviour.
• Good communicator and fluent in English, both in writing and speaking

Interested candidates should submit an updated CV.

Please apply by sending an up-to-date CV to [e-mail]

Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland.