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Associate MDR/Vigilance Specialist

Job Title: Associate MDR/Vigilance Specialist
Contract Type: Permanent
Location: Galway
Industry:
REF: 93542
Job Published: 7 months ago

Job Description

Contact: Bimi Felix
Email: bimi@hero.ie
Telephone: 086 8395533

Associate MDR/Vigilance Specialist
Our client, a medical device company in Galway are currently looking to recruit an Associate MDR/Vigilance Specialist for their site.

Our Offer
  • You will be responsible for the co-ordination of complaint handling activities for a wide range of products.
  • You will be responsible for the receipt and documenting of incoming complaint events.
  • You will also be responsible for co-ordination of cross-functional activities in the investigation of customer complaints and determination of root cause.
  • You will also support Vigilance and Medical Device Report (MDR) programs including adverse event reporting, preparing documentation on adverse events and ensuring timely submission with relevant regulatory agencies.
  • You will also support the response to any queries received from regulatory agencies in relation to complaint events or post market regulatory reports.
  • You will also support complaint trend analysis and issuance of key report to relevant departments.
  • You will support risk management, risk analysis and health hazard analysis associated with complaint/post-market information.
  • You will contribute to continuous improvement activities to support the role out of cell operating systems and principles within the PXM department.

Qualifications
Your Profile
  • We are looking for a qualified person to Bachelor’s degree (Level 8 NFQ) in Engineering/Science or related discipline and preferably with 1-2 years relevant experience in a medical devices or related environment.
  • Candidates with a legal or clinical qualification (e.g. registered nurse or experience in physiological or clinical measurement science) will also be considered.
  • We are looking for a dynamic team player who can work effectively and proactively on cross-functional teams.
  • Experience/understanding of complaint handling or CAPA processes are desirable.
  • Candidates must be able to think critically and make sound decisions.
  • Candidates must be focused on patient safety and customer service, set high standards, instils operational excellence, drive accountability and model ethical behaviour.
  • Candidates must be a good communicator and are fluent in English, both in writing and speaking.

For further information on this Associate MDR/Vigilance Specialist role in Galway please contact Bimi Felix on 086 8395533 / bimi@hero.ie

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