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
...
Job Description Support execution and implementation of Regulatory strategies, including adhering to project timelines and prioritizing deliverables.Responsible for generating and delivering documentation for life cycle management and registration of products domestically.Coordinates the assessment of product changes to capture any impact on existing or in-process product registrations and letters to file.Coordinates and documents regulatory activities for clinical studies as needed.Assist in submission activities for new product approvals and maintenance of on-market products, and may include support for pre-submissions, Premarket approvals (PMAs), Conformity assessments, IDE submission, Annual Reports, Export certificates, etc.Ability to negotiate with PMDA/MHLW to bring submission/approval effectively.Ability to work in a fast-paced environment and maintain a “focused urgency” as specific events require.Ability to work cross-functionally and communicate regulatory requirements to project teams as needed.Assists in implementing department procedures and regulatory processes.Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues relevant to assigned projects in the geography and discipline.Effectively communicate updates on assigned projects and changes in the regulatory landscape to team members and managers.
求められる経験
Qualifications
Master’s or bachelor’s degree in life sciences, engineering, public health, or equivalent.
+5 years of experience of regulatory affairs under Japanese regulatory affairs regulations in the IVD, medical device industry. Preferable genetic testing, precision medicine, and oncology experiences.
Familiar with regulatory issues and challenges associated with medical device development.
Knowledgeable in regulatory strategy creation, design control, and QMS.
Experience providing RA feedback to cross-functional project teams, providing active and successful regulatory guidance and RA strategies.
Experience in supporting and maintaining product approvals and registrations.
General understanding of genomic/molecular technologies and their impact on outcomes and diagnostic results.
Strong organizational skills and excellent oral and written communication skills.
Attention to detail, ability to compile data, summarize results and handle multiple tasks to prioritize and schedule work to meet business needs.
Ability to meet timelines and work across varied functions, cultures, and backgrounds.
English proficiency: advanced preferred
Japanese fluent
保険
健康保険 厚生年金保険 雇用保険
休日休暇
日曜日,土曜日,祝日
給与
年収900 ～ 1,400万円
賞与
-
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
Job Description Support execution and implementation of Regulatory strategies, including adhering to project timelines and prioritizing deliverables.Responsible for generating and delivering documentation for life cycle management and registration of products domestically.Coordinates the assessment of product changes to capture any impact on existing or in-process product registrations and letters to file.Coordinates and documents regulatory activities for clinical studies as needed.Assist in submission activities for new product approvals and maintenance of on-market products, and may include support for pre-submissions, Premarket approvals (PMAs), Conformity assessments, IDE submission, Annual Reports, Export certificates, etc.Ability to negotiate with PMDA/MHLW to bring submission/approval effectively.Ability to work in a fast-paced environment and maintain a “focused urgency” as specific events require.Ability to work cross-functionally and communicate regulatory requirements to project teams as needed.Assists in implementing department procedures and regulatory processes.Acquire and maintain current knowledge of applicable regulatory requirements and scientific/technical issues relevant to assigned projects in the geography and discipline.Effectively communicate updates on assigned projects and changes in the regulatory landscape to team members and managers.
...
求められる経験
Qualifications
Master’s or bachelor’s degree in life sciences, engineering, public health, or equivalent.
+5 years of experience of regulatory affairs under Japanese regulatory affairs regulations in the IVD, medical device industry. Preferable genetic testing, precision medicine, and oncology experiences.
Familiar with regulatory issues and challenges associated with medical device development.
Knowledgeable in regulatory strategy creation, design control, and QMS.
Experience providing RA feedback to cross-functional project teams, providing active and successful regulatory guidance and RA strategies.
Experience in supporting and maintaining product approvals and registrations.
General understanding of genomic/molecular technologies and their impact on outcomes and diagnostic results.
Strong organizational skills and excellent oral and written communication skills.
Attention to detail, ability to compile data, summarize results and handle multiple tasks to prioritize and schedule work to meet business needs.
Ability to meet timelines and work across varied functions, cultures, and backgrounds.
English proficiency: advanced preferred
Japanese fluent
保険
健康保険 厚生年金保険 雇用保険
休日休暇
日曜日,土曜日,祝日
給与
年収900 ～ 1,400万円
賞与
-
show more
