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Référence :


Lieu :

Paris et Région parisienne

Descriptif :

Job Purpose and Primary Objective
To support in all the vigilance activities/ daily complaints handling/ / evaluation of the reportability to health authorities /safety activities.

• Record complaints in the complaint database (when there is a need)
• Verify the information available in the complaints recorded
• Ensure that the complaints are handled in accordance with the complaints process
• Ensure that the initial vigilance assessment is done within the reporting timeframe and ensure appropriate reporting to National Competent Authorities (NCA)
• Follow-up the investigations of the complaints and ensure that the results are traced, and investigation parts are well documented
• Ensure that the investigations part is coded homogenously. If not, to discuss with the Quality control team
• Prepare the final vigilance assessment in accordance with the results of the investigations
• Closing the complaints when appropriate and contributing to the reduction of the complaints backlog
• Communicate with the multifunctional team/ concerned departments about new findings (need to create NC, CAPA or any corrective/preventive actions…) and leading Field Safety Corrective Action activities if there is a need
• Liaising with the different actors involved in the complaints process (Customer support, R&D, manufacturing…)
• Liaising with NCA when there are questions regarding complaints, with the support of the Regulatory affairs director
• Undertake any other specific tasks (contribution to the update of the processes, trending activities…) that could be requested during the contract period
• Ensure own compliance with health and safety regulations

Education / Professional attainments required by candidates
• Biomedical engineer or Medical background/ suitable technical/scientific qualification with a relevant vigilance experience
• Knowledge of relevant international standards, regulations and guidelines (EU Directives, MEDDEV guidelines, FDA CFR 820, ISO 13485)
Work experience: Minimum 2 years in the medical device industry in similar position
Desirable: Experience of the medical device sector and/or knowledge in diabetes

Experience and competencies
• Excellent oral, written, cross functional and interpersonal communication skills that are appropriate for various levels, including other departments and external stakeholders
• Be able to work independently and as part of a team showing good inter-personal and information transfer skills
• Project and results oriented
• Analytical and problem-solving approach and results oriented
• IT: Versatile with Microsoft Office (Word, Excel, Power-point)

Language: Must be fluent in both French and English

Contact :


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