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Associate MDR & Vigilance Specialist

ID
14806
Location
Galway, Ireland
Role Type
Contract
Contact
Hannah Doyle
Email
engineering@hero.ie
Phone
+353 86 107 0950
LinkedIn
click here

Associate MDR & Vigilance Specialist

Similar Jobs
Associate MDR & Vigilance Specialist
Location: Galway, Ireland
Duration: 23 month Contract
Job Type: Hybrid

Are you passionate about making a difference in the medical devices industry? Our client, a leader in healthcare innovation, is seeking an Associate MDR & Vigilance Specialist to join their dynamic team in Galway, Ireland. This role offers the opportunity to contribute to life-changing technologies while growing your career in a supportive and forward-thinking environment.

Key Responsibilities
  • Complaint Management: Coordinates the complaint handling process for a range of medical products, with a particular focus on pacemakers. This includes the receipt, documentation, and investigation of complaints to determine root cause.
  • Regulatory Reporting: Ensures accurate maintenance and reporting of Medical Device Reports (MDRs) as required by global regulatory agencies. Supports responses to any queries from these agencies related to complaints or post-market reports.
  • Cross-Functional Collaboration: Works closely with teams in Galway and the US, facilitating effective communication and teamwork to drive successful outcomes.
  • Risk Management: Supports risk management processes, including risk analysis and health hazard assessments associated with complaints and post-market information.
  • Continuous Improvement: Contributes to ongoing improvement initiatives within the Complaint and Quality Management (CQXM) department, helping to roll out cell operating systems and principles.
Top Skills & Experience
  • Educational Background: Holds a Bachelor's degree (Level 8 NFQ) in Engineering, Science, Legal, Clinical, or a related discipline.
  • Industry Experience: Brings 1-2 years of experience in a medical devices or similar regulated environment.
  • Critical Thinking: Demonstrates the ability to think critically, make sound decisions, and pay strong attention to detail.
  • Technical Knowledge: Has a solid understanding of basic anatomy, physiology, and medical terminology.
  • Communication Skills: Possesses excellent communication skills, with fluency in English, both written and spoken.
  • Customer Focus: Maintains a strong focus on patient safety and customer service, setting high standards for operational excellence.
Specialist Career Stream
  • This role is ideal for an entry-level professional looking to make an impact in a highly regulated industry. The position offers close supervision and mentoring opportunities, enabling the Associate MDR & Vigilance Specialist to grow their skills while contributing to smaller, yet impactful projects.
Why Choose Galway?
  • Set against the stunning backdrop of the Wild Atlantic Way, Galway offers an exceptional quality of life, vibrant community, and rich cultural heritage, making it an ideal place to live and work.
Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters.

For further information on this role please contact Hannah Doyle on 086 107 0950 or Engineering@hero.ie. Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval. Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.
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