Simone Ceretti
Regulatory Affairs Manager at RAND Srl- Claim this Profile
Contact Information
us****@****om
(386) 825-5501
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Location
Bagnolo in Piano, Emilia-Romagna, Italy, IT
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Experience
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RAND Srl
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Italy
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Software Development
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1 - 100 Employee
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Regulatory Affairs Manager
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Mar 2010 - Present
- Preparation and maintenance of the products’ Technical Files for the CE marking. - Collection of the documentation and preparation of the product dossiers for the international registration (USA, Latin America, Canada, Middle East, China…). - Member of the risk management team. - Preparation and maintenance of the clinical evaluation document. - Responsible for qualification and requalification of the EtO sterilization process. - Post-market surveillance (decision for reporting of events to Competent Authorities) - Backup to Quality Assurance Manager Show less
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Covidien
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United States
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Medical Device
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Regulatory Affairs Specialist
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Nov 2003 - Feb 2010
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Education
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Università di Bologna / University of Bologna
Chemistry
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