The role is for a bilingual RAQA professional with a pharmacist license in Fukuoka. For this role you will be responsible for RA & QA activities while taking on the responsibilities of the general marketing supervisor under the PMD act.
Snapshot of the duties:
・QA for medical device and medicinal products (QMS/GQP)
・Complaint handling for medical device and medicinal products
・Regulatory filings: Shonin and Ninsho submission for medical device
・Business license: Registration, change registration, renewal of MAH, manufacturer, seller licenses
・Reimbursement: Submission of reimbursement application to MHLW economic department
Requirements of the job:
(1) Pharmacist qualification (must)
(2) Working experience QA, post-marketing safety control, RA, product development of medicinal product (must)
(3) Experience of holding the general marketing supervisor role (preferred)
(4) Business English communication ability (Speaking and writing skill: e.g. TOEIC 650) (Plus)
※To be the general marketing supervisor, you need 3 years of experience for quality control. But, those with less than 3 years of experience will be able to accumulate the experience after joining the company.
※(3)~(4) not necessary. Training and support will be provided after joining.
About the company:
- Over 25 yrs old, with Euro HQ
- Global care leader in: kidney disease, dialysis, hemodialysis, home dialysis, renal care
- SDG push: 105 environmental initiatives across 42 production sites globally
- Chance to work around the world.
- Training & development for career growth & advancement
- Big Diversity & Inclusion drive: Women's Leadership Initiative, a group of 14 female leaders across the company's Asia-Pacific offices