社名
社名非公開
職種
薬事、メディカルライティング
業務内容
...
Identify regulatory and post-market requirements for new products or enhancements early in development. Gather information for regulatory submissions and compliance activities. Review product revisions for compliance with regulatory standards. Provide necessary information for new product launches.Develop regulatory strategy with product teams based on current requirements.Review and approve labelling and marketing materials for Japan.Support regulatory and compliance matters, completing tasks assigned by the supervisor.Identify key policy initiatives with line manager and senior stakeholders. Recommend government affairs positions to upper management.Lead Recall and Adverse Event reporting in Japan, ensuring compliance with local regulations.Archive and maintain submission documents properly.Protect and manage confidential information appropriately.Apply for necessary permits for products or sites.Ensure the Japan office complies with regulatory standards and participate in audits.Develop and maintain quality system processes and document control.Utilize the CAPA system for corrective and preventive actions.Collect and analyze quality data for Quality Management Reviews.Manage supplier compliance and performance.
求められる経験
5 years of solid experience with a proven track record in Japan Medical Device Regulatory Affairs and Quality Affairs.
Familiar with Japan's standards and regulations for Class I, Class II, and Class III Medical Devices.
Positive working attitude and responsive.
Meticulous, precise, and analytical.
Self-starter who can work independently with minimal supervision.
Strong organizational, time management, project management, and problem-solving skills.
Excellent communication skills and a good team player.
Proficient in English speaking and writing.
Able to work under pressure to meet deadlines and willing to work additional hours for conference calls as needed.
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900 ~ 1,250万円
賞与
1200000
雇用期間
期間の定めなし
show more
社名
社名非公開
職種
薬事、メディカルライティング
業務内容
Identify regulatory and post-market requirements for new products or enhancements early in development. Gather information for regulatory submissions and compliance activities. Review product revisions for compliance with regulatory standards. Provide necessary information for new product launches.Develop regulatory strategy with product teams based on current requirements.Review and approve labelling and marketing materials for Japan.Support regulatory and compliance matters, completing tasks assigned by the supervisor.Identify key policy initiatives with line manager and senior stakeholders. Recommend government affairs positions to upper management.Lead Recall and Adverse Event reporting in Japan, ensuring compliance with local regulations.Archive and maintain submission documents properly.Protect and manage confidential information appropriately.Apply for necessary permits for products or sites.Ensure the Japan office complies with regulatory standards and participate in audits.Develop and maintain quality system processes and document control.Utilize the CAPA system for corrective and preventive actions.Collect and analyze quality data for Quality Management Reviews.Manage supplier compliance and performance.
...
求められる経験
5 years of solid experience with a proven track record in Japan Medical Device Regulatory Affairs and Quality Affairs.
Familiar with Japan's standards and regulations for Class I, Class II, and Class III Medical Devices.
Positive working attitude and responsive.
Meticulous, precise, and analytical.
Self-starter who can work independently with minimal supervision.
Strong organizational, time management, project management, and problem-solving skills.
Excellent communication skills and a good team player.
Proficient in English speaking and writing.
Able to work under pressure to meet deadlines and willing to work additional hours for conference calls as needed.
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900 ~ 1,250万円
賞与
1200000
雇用期間
期間の定めなし
show more