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Medical Devices Company jobs in Spiddal, County Galway

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Job Post Details

Associate MDR/Vigilance Specialist
PE Global
·
4.0
Galway, County Galway
•
Hybrid work
Full-time
Apply now

Job details

Pay information not provided
Full-time
Hybrid work in Galway, County Galway

Full job description

The Role

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

Job Responsibilities

  • Receive, document and coordinate incoming product complaints, ensuring records are accurate and complete.
  • Coordinate cross-functional complaint investigations and support root cause determination.
  • Support post-market surveillance activities, including the evaluation, processing and follow-up of adverse event reports.
  • Maintain complete and accurate Medical Device Reports (MDRs) and other applicable safety reports in line with regulatory requirements.
  • Support responses to regulatory agency queries relating to complaint events and post-market reports.
  • Review and analyse complaint and safety data to support accurate reporting and high-quality safety summaries.
  • Contribute to risk management, risk analysis and health hazard assessments associated with complaint and post-market information.
  • Collaborate with internal stakeholders and external partners to support regulatory reporting processes.
  • Contribute to continuous improvement initiatives, including the rollout of cell operating systems and principles within the CQXM department.
  • Complete assigned tasks and project activities in accordance with company policies and procedures.


Education & Experience

  • A bachelor’s degree at NFQ Level 8, or equivalent, in Engineering, Science, Law, a clinical discipline or a related field.
  • Previous experience in a medical device or related environment is desirable; 1–2 years of relevant experience is preferred, but not essential.
  • Basic knowledge of anatomy, physiology and medical terminology.
  • Strong attention to detail and a commitment to accurate documentation.
  • Critical thinking, problem-solving and sound decision-making skills.
  • A proactive, collaborative approach to working with cross-functional teams.
  • Strong written and verbal communication skills, with fluency in English.
  • A commitment to customer service, ethical conduct and accountability.


Interested candidates should submit an updated CV.

Please click the link below to apply, alternatively send an up-to-date CV aisling.oleary@peglobal.net

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

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