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薬事スペシャリスト

年収:800万 ~ 1100万

ヘッドハンター案件

部署・役職名 薬事スペシャリスト
職種
業種
勤務地
仕事内容 Key Responsibilities
- Execute action related regulatory compliance by having preventive and avoidance action doing risk analysis and management in RA part.
- Take action to inquiry and/or instruction from Health Authority as a representative from Business Unit Regulatory Affairs in the company.
- Establish RA strategy (incl. incl. clinical study/clinical evaluation strategy) for new product introduction by collaborating internally and having discussion and negotiation with Health Authority
- Will report to Business Unit Regulatory Affairs manager or Head. The Business Unit will be determined considering the candidate’s experience and preference.
応募資格

【必須(MUST)】

- Bachelor's degree or an equivalent qualification is required, and an advanced degree is preferred.
- Experienced Class II/III/IV Medical Device regulatory submission at least 3 years (especially negotiation experience with PMDA/MHLW related to regulatory submission/approval)
- Native level of proficiency in Japanese and business level of English proficiency

Skills & Competencies
- Project management
- Stakeholder management
- Self-development
- Adaptability

【歓迎(WANT)】

- Basic RA/QA/VS knowledge and rich experiences (at least 5 years) in communication of regulatory requirements and regulatory issues.
- Experience of Class III/IV Medical Device regulatory submission leveraging Clinical Study Report/Clinical Evaluation Report (CSR/CER) is highly regarded
- Strong scientific background (e.g. medical engineering, Regulatory science, Biology, Chemical, Mechanical Engineering, Electrical Engineering)

リモートワーク

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その他

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更新日 2024/02/16
求人番号 3301710

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