メディカル・バイオ - 薬事申請

MAIN OBJECTIVE:
Regulatory input is required at all levels of the Medical Devices and the involvement of the Regulatory Affairs. The main responsibility of the Regulatory Affairs member is to plan and execute all activities necessary for the registration of product changes such as maintenance of regulatory documents and updating and applying for regulatory requirements related PMD Act.

ESSENTIAL DUTIES AND RESPONSIBILITIES:
1)Change control of already-approved products including regulatory submissions
•Collects, assesses, and reports product change information
•Develops strategy for required actions
•Plans change submission schedule and monitors the status
•Prepare reimbursement submissions for changes, if necessary
2)RA Document control
•Collects updated PMD Act related notices and takes necessary actions
•Collects information directly from the industry to secure company’s benefits
3)Education and training for developing skills
•Attends to seminars, lectures and academic conferences to collect and share information
•Researches and makes best use of literatures and academic books
•Improves work efficiency

■休日：完全週休二日制, 土, 日, 祝日, 年末年始

EDUCATION AND EXPERIENCE
•Experience of minimum 3 years in regulatory affairs in the medical device industry
•Bachelor degree
•Bachelor of science or engineering degree preferred

Knowledge and Skill Requirements/Specialized Courses and/or Training:
•Working knowledge of the latest PMD Act is indispensable
•Knowledge of submission for Class III & IV implant in Orthopedics area under the latest PMD Act preferred
•Knowledge of submission with clinical trial data for Orthopedics product highly desirable
•Knowledge of biological safety area preferred
•Knowledge of the business goals, products, therapy, customer needs, reimbursement, and competitive environment preferred

Machine, Tools, and/or Equipment Skills:
•PC skills (Excel, Word, Power Point)

Reasoning Ability:
•Recognize issues and analyze their causes in order to reach a solution
•Knowing where to locate needed information to solve questions or clarifications
•Detail oriented and thorough

Mathematical Skills
•Require mathematical skills to be able to cope with making calculations such as statistic calculation, mechanical calculation and unit conversion

Language and Communication Skills:
•Excellent verbal, writing and reading skills in Japanese
•Business level English skill
•Communication ability in order to build solid relationships with MHLW and PMDA
•Communication ability for effective and positive relationship with other division members

■職種未経験者：不可