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Updated 2022-09-30
Activated 2022-09-19

Pharmaceutical Affairs [Japanese x English]
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  • Recruiter
  • Senior Level
  • No Transfer
  • No Age Restriction
This posting is managed by: j Career Co.,Ltd. / 株式会社 j Career
Company Name Company is not publicly visible
Job Type
j Career Co.,Ltd. / 株式会社 j Career
Medical/Pharmaceutical/Bio/Fabric/Food - Patent
Medical/Pharmaceutical/Bio/Fabric/Food - Other
Administrative - International Affairs
Industry Medical devices
Location Asia Japan Tokyo Shinjuku

Job Description You will be engaged in handling regulatory applications for medical devices (Pharmaceutical Machinery Law Classes 1 to 3).

・ Preparation of regulatory application documents
・ Prior consultation, inquiry, and investigation regarding regulatory applications with PMDA and third-party certification bodies
・ Manufacturing and sales business, manufacturing business, sales business, repair business business format management business
・ Activities to collect legal and regulatory information from domestic and overseas regulatory authorities
・ Support for QMS conformity survey and ISO13485 audit
Company Info Medical device manufacturer
* No smoking in the office
Working Hours Flextime
Job
Requirements
MUST
・ More than 3 years of regulatory experience

WANT
・ Pharmacist qualification
English Level Business Conversation Level (TOEIC 735-860)
Japanese Level Fluent(JLPT Level 1 or N1)
Salary JPY - Japanese Yen JPY 5000K - JPY 8000K   
Other Salary
Description
Social Insurance
Commuting/ Transportation Allowance
Holidays Five-Day Workweek
Summer Holidays
Winter Holidays
Paid Holidays
Congratulatory or Condolence Leave
Child-care Leave
Sick Leave
Job Contract
Period
Full-time employee
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