Medical Device Vigilance Specialist (H/F)
The Medical Device Vigilance Specialist is responsible for maintaining the Medical Device Vigilance processes and ensuring related operational activities within the whole organization.
Identify necessary inputs for Medical Device Vigilance.
Analyze data received related to quality, safety or performances of medical devices after they have been placed on the market and record analysis output.
Ensure follow up of safety complaints (issues raising a risk of harm to someone excluding employees of the company ).
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 products (e.g. technical and risk experts, marketing authorization holders).
- Knowledge of Medical Devices Directive mandatory
- Background: Medical, clinical or scientific (may be also a nurse, a doctor, …)
- Junior profiles are also welcome
- Very good English knowledge
- Well organized
Our client, a company active worldwide in the field of biotechnology, offers you a 6 - month mission from the end of August to the end of October with the possibility of a fixed contract.
Salary and Benefits
Your salary package will be based on your experience and your skills.