社名
社名非公開
職種
安全性管理、品質保証、品質管理
業務内容
...
• Serving as the appointed Safety Manager, ensuring adherence to relevant regulations outlined in GVP ordinance 135 of the PMDA Act.• Proactively taking steps to promptly and effectively implement any necessary Field Safety Corrective Actions.• Conducting timely and efficient reporting of complaints, as well as handling, reviewing, and submitting foreign adverse event reports to PMDA in accordance with GVP ordinance 135.• Promptly and efficiently addressing any findings from local internal or external audits, in coordination with applicable Business Units.• Ensuring ongoing compliance with local regulations and applicable regulatory requirements.• Reporting to the Senior Manager, receiving training and guidance from the Commercial Quality organization, and collaborating with local commercial operations, the commercial quality team, and global customer quality teams from respective BUs.
求められる経験
• Proficient understanding of Medical Device regulations in Japan
• Effective business-level English proficiency in both verbal and written communication, with a TOEIC Score exceeding 840.
• Advanced skills in MS applications (Word, Excel, PowerPoint, etc.).
• Strong communication abilities, including logical/critical thinking and negotiation skills with competent authorities (PMDA/TMG/MHLW), as well as a collaborative mindset for teamwork within internal and external teams.
• Minimum bachelor's degree required (preferably in a technology or natural science field).
• More than 5 years of experience working in a regulated industry within the Quality organization and at least 5 years of experience at Safety Divison in a Medical Device Company (dealing or manufacturing devices with Class 3 or higher) in accordance with local GVP regulations.
• Expertise in complaint handling
保険
健康保険 厚生年金保険 雇用保険
休日休暇
土曜日 日曜日 祝日
給与
年収700 ~ 1,100万円
賞与
1000000
show more
社名
社名非公開
職種
安全性管理、品質保証、品質管理
業務内容
• Serving as the appointed Safety Manager, ensuring adherence to relevant regulations outlined in GVP ordinance 135 of the PMDA Act.• Proactively taking steps to promptly and effectively implement any necessary Field Safety Corrective Actions.• Conducting timely and efficient reporting of complaints, as well as handling, reviewing, and submitting foreign adverse event reports to PMDA in accordance with GVP ordinance 135.• Promptly and efficiently addressing any findings from local internal or external audits, in coordination with applicable Business Units.• Ensuring ongoing compliance with local regulations and applicable regulatory requirements.• Reporting to the Senior Manager, receiving training and guidance from the Commercial Quality organization, and collaborating with local commercial operations, the commercial quality team, and global customer quality teams from respective BUs.
求められる経験
• Proficient understanding of Medical Device regulations in Japan
• Effective business-level English proficiency in both verbal and written communication, with a TOEIC Score exceeding 840.
...
• Advanced skills in MS applications (Word, Excel, PowerPoint, etc.).
• Strong communication abilities, including logical/critical thinking and negotiation skills with competent authorities (PMDA/TMG/MHLW), as well as a collaborative mindset for teamwork within internal and external teams.
• Minimum bachelor's degree required (preferably in a technology or natural science field).
• More than 5 years of experience working in a regulated industry within the Quality organization and at least 5 years of experience at Safety Divison in a Medical Device Company (dealing or manufacturing devices with Class 3 or higher) in accordance with local GVP regulations.
• Expertise in complaint handling
保険
健康保険 厚生年金保険 雇用保険
休日休暇
土曜日 日曜日 祝日
給与
年収700 ~ 1,100万円
賞与
1000000
show more