Manage and participate in the improvement of the materiovigilance system in accordance with the regulations in force:
- Record reports, vigilance claims that are reported,
- Coordinate the overall post-market surveillance activity within the different departments concerned (distribution center, hospitals)
- Analyze trends and implement corrective and preventive actions,
- Respond to customers,
- Prepare vigilance declarations (PSUR), in order to have them validated by the Vigilance Manager (PRRC),
- Respond to additional questions from the authorities,
- Process data relating to incidents of which the company is aware.
Manage Quality Product projects (around 30% of the effective task)
Carry out internal audits,
Participate in product risk management,
Write technical documentation.
- Proven experience as Engineer with knowledge of manufacturing processes / materials in a orthopedics Medical Device company
- Good knowledge of ISO 13485 / MD European and American regulations
- Fluent in English and French with writing skills in English
- Solution oriented, rigorous, and organized