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JPN_【RA】RA Specialist Job

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Date: Feb 14, 2021

Location: Tokyo, 13, JP

Company: Boston Scientific

【業務内容】
Ensures rapid and timely approvals for respective product lines by plans on all product registration, manage all product registrations' preparation and documentation. Interacts
with regulatory agency personnel in order to expedite approval of pending registration and answers any questions on product documentation. Provide management team with regular
updates on product registration and new regulations from government body.
•Provides input on regulatory related issues associated with compliance and achieving the business plan.
•Prioritize and plan on product registration for his/her respective product
•Preparing, coordinating and submitting regulatory applications to the local health authority.
•Maintain an active knowledge of the status of pending approvals and shepherd registrations through the approval process. Provide the management team with
regular updates on product registration.
•Establish and implement plans to maintain a trusted relationship with the local health authorities through regular meetings, discussions, training and education.
•Lobby the local health authorities using constructive/scientific challenges to regulations. This should include guidance on alternative solutions to country regulatory needs.
•Supports tender operations by timely supply of accurate regulatory
•Establishes relationships with local medical device industry groups and works with industry peers to lobby the Competent Authorities in matters of regulatory issues and
to influence local policies.
•Establish and maintain a good working relationship with regional RA peers to gain positive & timely support for document preparation.
•Serves as regulatory consultant to marketing team and government regulatory agencies.
•Complete the mandatory Quality training subject to the defined timeline. And ensure compliance with internal Quality system and policy.

 

【必須経験やスキル】
• 薬事申請経験
• 英語:ビジネスレベル
• 既存の戦略やプロセスに固執することなく Proactive に自ら考え立案し交渉できる
• 事業部、事業部、PMDAPMDA、グローバルとの難しい交渉を単独でマネージできる、グローバルとの難しい交渉を単独でマネージできる
• すべての情報が揃わなくても動き始めるすべての情報が揃わなくても動き始めるAgilityがある
• 変化を前向きに解釈し前に進む。臨機応変に変化を捉えるビジネスセンスをも変化を前向きに解釈し前に進む。臨機応変に変化を捉えるビジネスセンスをもっているっている

 

【勤務地】
本社(東京都中野区)

Boston Scientific


Job Segment: Medical, Law, Supply, Compliance, Medical Device, Healthcare, Legal, Operations