MEDICAL DEVICE Vigilance Specialist (m/f)
That's XPE. For one of our clients we are looking for: MEDICAL DEVICE Vigilance Specialist (m/f) Organisation description:
At XPE Pharma we're looking for a Medical Device Vigilance Specialist who will be responsible for creating, developing and maintaining the Medical Device Vigilance processes and ensuring related operational activities within the organization.Job description:
As Medical Device Vigilance Specialist, your main tasks are:
• Identify necessary inputs for Medical Device Vigilance. Analyze data received related to quality, safety or performances of medical devices and similar systems after they have been placed on the market and record analysis output. Collect proactively and analyze alerts on systems similar to medical devices through market screening, define actions and provide corresponding records.
• Ensure follow up of safety complaints (issues raising a risk of harm to someone excluding company employees ). Collaborate with the whole organization and ensure leadership regarding action plan of safety complaints. Identify safety issues to be escalated to management.
• Prepare customer or internal communication for safety complaints deemed necessary with support of other departments.
• Analyze safety complaints and output of trends in complaints and incidents to determine and document the need to report to competent authorities based on regulations and risk assessment. Prepare and submit the report to competent authorities in a timely manner. Follow up implementation of corrective and preventive actions until report final closure.
• Handle interaction with the US agent for FDA, notified body, other competent authorities and stakeholders which need to be involved in Medical Device Vigilance of company products (e.g. technical and risk experts, marketing authorization holders).
• Maintain compliance of procedures to regulations related to Medical Device Vigilance and update it based on information received from regulatory watch.
• Manage training to external and internal customers about medical device reporting and medical device vigilance.Profile:
To join our team, you have:
A good knowledge of Medical Devices Directive!
A medical, clinical or scientific background
A first industry experience (at least a long internship or other experience)
Good command of English
Available from May until OctoberOffer:
5 months mission (May-October 2018)
A package in line with your experience
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002 XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713