+15 years of experienced regulatory submission specialist in a broad range of product areas.
Varian Medical Systems K.K.
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Senior Regulatory Affairs SpecialistVarian Medical Systems K.K. Mar 2017 - PresentResponsible for regulatory submissions for all the Varian hardware products.
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Regulatory Affairs Project ManagerZimmer Biomet G.K. May 2014 - Feb 2017Responsible for regulatory submissions for all the Zimmer trauma products.- Developed regulatory strategy in order to achieve local marketing business target.- Prepared Class 1-3 Implant device new product submissions / partial change submissions- Prepared Reimbursement submissions- Managed Change control (information gathering and regulatory assessment)- Coaching (regulatory submission document, biomaterial for implant devices)- Communication with global business unit and local marketing team
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Regulatory Affairs SpecialistCovidien Japan K.K. Mar 2012 - Apr 2014Regulatory submission work for Vascular therapy/Airway management device.- Class 1-4 Vascular therapy/Airway management device new product submissions / partial change submissions- Change Management (information gathering and regulatory assessment)- Communication with global business unit and local marketing team
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Regulatory AffairsStryker Japan K.K. Apr 2008 - Feb 2012
Daichi Nishimura Education Details
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Tokyo Medical And Dental UniversityBiomaterial -
Yamagata UniversityChemistry And Chemical Engineering
Frequently Asked Questions about Daichi Nishimura
What company does Daichi Nishimura work for?
Daichi Nishimura works for Varian Medical Systems K.k.
What is Daichi Nishimura's role at the current company?
Daichi Nishimura's current role is Senior Regulatory Affairs Specialist at Varian Medical Systems K.K..
What schools did Daichi Nishimura attend?
Daichi Nishimura attended Tokyo Medical And Dental University, Yamagata University.
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