Medical Devices
Medical Devices

International Vigilance Specialist

UK&I

Scope

Consult is leading a search for an International Vigilance Specialist on behalf of a global Medical Device manufacturer - Who has recently signed global agreements with Apple and Microsoft to collaborate on their integrated solutions.

Responsibilities

  • Review decision-trees and other supporting information in the Complaint System, in order to determine whether incidents are reportable as per applicable Regulations in conjunction with the wider team. Document rationales/reporting decisions and challenge decisions where necessary and advise Vigilance Manager wherever appropriate.
  • Prepare and file Initial and Final Device Vigilance Reports, as required, for all Incidents deemed reportable in accordance with reporting timeframes.
  • Liaise with all key stakeholders, (customers, distributors, customer-facing teams, service and engineering teams, in-country QA & RA personnel, etc), to acquire additional information/clarification, as needed, to determine a decision on reportability.
  • Planning & execution of Field Safety Corrective Actions (FSCA) activities where necessary.

About You

  • Working in a Vigilance/Quality/Regulatory/Post-Market division within the medical device, pharmaceutical, or other highly regulated industries
  • Medical Device Directive (MDD), Medical Device Regulations (MDR), MEDDEVs, Field Safety Corrective Actions (FSCA) other associated Directives.
  • Reviewing processes and information within a Complaint Systems to determine whether incidents are reportable under relevant regulations
  • Initial and Final Device Vigilance Reports
  • Knowledge of applicable regulations, standards, and quality systems related to medical device internationally (for example ISO 9001, ISO 13485, QSR)
  • Use of Documentation Systems (eg Agile, EtQ, SAP, JDE).
  • Ability to independently plan, execute, and/or problem-solve in complex situations.
  • Ability to manage multiple projects
If you are interested in the above role then please apply or get in touch to discuss further.
Tanya Boyes Managed by Tanya Boyes
highlights
National
Permanent
QA/Regs
apply Posted - 21.04.2021

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Consult will endeavour to contact candidates within 14 days of application. However, if you do not hear back after 2 weeks then please assume on this occasion, unfortunately, you have not been successful.