Job Detail

Location Galway
Salary Negotiable
Role Type Temporary
Contact Marchon Monroe

MDR Vigilance Specialist

MDR Vigilance Specialist (Medical Device Complaint Handling & Regulatory Reporting)

Our client is a well know Galway multinational with a new contract opportunity for a MDR Vigilance Specialist to join on an initial 12 month contract. This role is working within the Complaint Handling & Regulatory Reporting Department were you will focus on complaint handling and post market regulatory reporting activities. As the Vigilance Specialist, you will be part of a high performing team and be given extensive training on the products, Complaint Handling and Medical Device Regulatory reporting. This is a role where you will provide immense value through world class execution in Medical Device Reporting and Vigilance compliance.

Key Responsibilities:

  • Co-ordination of complaint handling activities for a wide range of products including receipt and documenting of incoming complaint events.
  • Support complaint trend analysis and issuance of key report to relevant departments.
  • Support the response to any queries received from regulatory agencies in relation to complaint events or post market regulatory reports.
  • Support risk management, risk analysis and health hazard analysis associated with complaint/post-market information.
  • Contribute to continuous improvement activities to support the role out of cell operating systems and principles within the product department.
  • Monitoring 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.
  • Ensure 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.
  • Standardization and internalization as well as to ensure the accuracy and quality of safety summaries.
  • Co-ordination of cross-functional activities in the investigation of customer complaints and determination of root cause.
  • Act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements.

Education, Experience and Skills:

  • Bachelor’s degree in Engineering/Science or related discipline.
  • 1-3 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.
  • Experience/understanding of complaint handling or CAPA processes are desirable.
  • Team player who can work effectively and proactively on cross-functional teams as this role is working from home for the foreseeable future. Excellent training will be proved!
  • Focus on patient safety and customer service, set high standards, instills operational excellence, drive accountability and model ethical behavior.
  • Excellent communicator who is fluent in English, both in writing and speaking.

For further information on this MDR Vigilance Specialist role in Galway, please contact Marchon Monroe on 0860449473 /
Check out all our open jobs on our HERO Recruitment website –

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.


  Apply with Linkedin   Apply with Indeed
MDR Vigilance Specialist

Marchon Monroe

Role Type Temporary
Contact Marchon Monroe
mobile +353 86 044 94 73
linkedIn profile click here

MDR Vigilance Specialist


MDR Vigilance Specialist (Medical Device Complaint Handling & Regulatory Reporting) Our client is a well know Galway multinational with a…


Read More

Sr. Regulatory Affairs Specialist


Senior Regulatory Affairs Specialist My client is a highly desirable Medical Device design and manufacturing company in Galway, and is…


Read More

Labelling Specialist


Labelling Specialist Job Summary: The Labelling Specialist will provide subject matter expertise on all aspects of label formation, design and…


Read More