社名非公開(医療機器メーカー)
薬事【シニアレベル】 No.80417041の求人・転職情報

Job No.80417041

募集要項

仕事内容

1. Creation of RA plan and application strategy for new product introduction, integration strategy (acquisition) and product or manufacturing change
2. Support RA manager for RA budget control
3. Schedule and control timeline of new submissions and maintenance activities for existing registration files
4. Submit applications
5. QMS application, audit arrangement and control of QMS certificate related to submission
6. Collaborate for new product introduction with stakeholders (Vigilance, Quality, Document Control Center, MKT, etc.) by contributing for Master data registration, issuance of Tenpubunsyo, transferring design documents and registration information/documents into DMR, etc.
7. Assess changes to existing registration files
8. Filing and maintenance of regulatory license
9. Collect/learn up-to-date regulatory requirements, input them into team or company-wide and plan/implement necessary actions or improve existing procedure

勤務地 東京都
予定年収 700万〜800万 ※経験に応ず
募集職種

会社概要

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