Materiovigilance Officer

  • Permanent
  • Geneva

Missions:

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.

 

Profile:

  • 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