募集要項
- 募集背景
- 新規製品導入の需要による新ポジション
- 仕事内容
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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
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- 必須
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Required
- 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
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- 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)
- 募集年齢(年齢制限理由)
- 定年60歳で、長期的によりキャリア形成を図る為 （長期勤続によりキャリア形成を図るため）
- 雇用形態
- 正社員
- 勤務地
- 埼玉県 / 千葉県 / 東京都 / 神奈川県 / 山梨県
- 年収・給与
- 600万円程度～ 1000万円程度
- 選考プロセス
- 面接2回
