募集要項
- 仕事内容
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Regulatory: To develop and execute product approval and regulatory strategies. Ensure compliance with all applicable domestic standards and regulations that pertain to regulatory approval and maintenance on the market; interpreting regulations and guidelines; ensure that overall regulatory activities are conducted and documented in accordance with Japan Pharmaceutical Affairs Law (PAL) requirements and guidelines, applicable national requirements and guidelines, and company procedures.
Quality Assurance/ Safety Management: Ensure compliance and product quality /safety required standard with regard to document control, reliability and quality engineering, quality control, safety management, complaint handling and other quality related functions.
- 応募資格
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- 必須
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【EDUCATION】
●Bachelor’s degree in Health Sciences, Biomedical engineering or related field required. Master’s degree desirable
【KNOWLEDGE AND EXPERIENCE】:
●A minimum of fifteen (15) years in the RAQA function, four to six (4-6) of these years must be experience at a manager-level.
●PAL medical device Shonin and Ninsho application preparation and management.
●Bilingual Japanese and English
●Basic knowledge of accounting and budgeting
●Lead and facilitated PMDA and/or MHLW meetings
【SKILLS AND ABILITIES】:
●Well-developed organizational skills required
●Advanced written and verbal communication skills
●Proficiency in Microsoft Office Suite, particularly Word and Excel
●Native in Japanese and fluent in English
- 歓迎
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●Previous practical experience in RAQA activities in cardiovascular medical device applications highly desirable
●Sokatsu experience is desirable
- 雇用形態
- 正社員
- 勤務地
- 東京都（最寄駅：品川駅）
- 勤務時間
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09:00 ～17:30
・フレックスタイム制(コアタイムは部門により異なる)
・休憩時間：６０分
・残業の有無：残業有り。その月により変動あり。
- 年収・給与
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想定年収： 800万円～1,300万円
昇 給： 1回
賞 与： 2回
- 待遇・福利厚生
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【各種社会保険完備】
・健康保険、雇用保険、厚生年金、労災保険
【福利厚生】
・カフェテリアプラン方式の充実の福利厚生メニュー
・総合福祉団体定期保険
・定期健康診断
・財形貯蓄制度
・団体扱い生命保険・損害保険
・法人契約リゾート施設
・社員食堂
- 休日休暇
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・完全週休2日制(土曜・日曜)
・祝日
・年末年始
