募集要項
- 仕事内容
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■Develop, manage and implement regulatory strategy to maintain existing product lines or support entry into new markets upon creation of new products
■Develop and implement reimbursement strategy to obtain adequate level of health insurance policy
■Manage communications with government / regulatory agencies and KOLs on a local basis
■Maintain and manage cooperative relationship with ISI regulatory, marketing and production teams to pursue Japan regulatory programs.
■Manage Japan RA function to develop and implement Japan regulatory strategy
■Establish and maintain relationship with government agencies, external regulatory related organizations and KOLs to carry out company RA strategies
■Plan and manage the growth in RA management functions
■Provide the timely new product introduction with necessary filing and communication
■Maintain the regulatory clearances with necessary filing and communication
- 応募資格
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- 必須
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■Minimum 10+ years of experience in submissions, technical documentation, and reimbursement for a medical device company
■Minimum of 7 year experience leading teams with a solid track record in hiring and developing team members
■Excellent ability to work in cross-functional environments
■Strong verbal and written communication skills, proven ability to translate technical documentation into effective regulatory submissions
■Good interpersonal and project management skills, with the ability to work well in a cross-functional environment
■Experience working directly with the MHLW/PMDA, Notified Bodies and other governmental agencies on Regulatory matters
■B.S. or higher in sciences. Biomedical Engineering, Electrical Engineering or Mechanical Engineering a plus. Masters’ degree preferred
- 雇用形態
- 正社員
- ポジション・役割
- Manager または Snr Manager
- 勤務地
- 東京都
- 勤務時間
- 9:00～18:00 (休憩1h)
- 年収・給与
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●年俸制
●想定年収700万円～1000万程度 （ご経験・前職給与を考慮の上、決定）
- 待遇・福利厚生
- 社会保険完備（健康保険・厚生年金・雇用保険・労災保険）
- 休日休暇
-
土日祝休み
12/29～1/4
その他特別に定めた日
