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1市販後品質不具合の解決推進2行政当局対応
医療機器の薬事申請担当者
薬事申請業務変更管理など
医療機器に関する品質保証業務QMS管理業務
承認申請業務を中心として幅広く医療機器の規制や開発に関わる業務を担当していただきます。
Directly reporting to the General Manager - Japan, you will oversee all assigned seminars and seminar activities of all Sales Reps of Japan, along with supervision of 9 dental hygienists located across Japan.
You will lead strategic direction and tactical implementation for the existing and emerging Structural Heart portfolios, focusing on patient-centric outcomes and optimal clinical adoption. You will also serve as the primary champion for the portfolios, overseeing all aspects from market analysis and opportunity assessments to long-term planning and new market entry strategies.
As the Director of Marketing for CRM products in Japan, you will lead business planning and market development, driving commercial planning, collaboration, and accountability to mobilize resources across the Company and execute product strategies effectively.
Take lead in PMS actvities for the business to ensure effective GVP compliance for the company. Support the Sokatsu.
The Senior Specialist in Product Marketing for Critical Care will play a pivotal role in executing marketing strategies, including product launch support and KOL relationship management, during the company's transition to an independent business entity. This position requires expertise in marketing principles, strong communication skills, and a commitment to improving patient care through innovative monitoring technologies.
The Manager of Clinical Marketing for Transcatheter portfolio will lead business expansion efforts by developing and disseminating compelling clinical content to stakeholders, driving market share growth. This role requires strong project management skills, regulatory knowledge, and a passion for driving results in the dynamic medical device industry.
The Manager of Market Access will lead strategic initiatives to ensure access to innovative healthcare solutions for structural heart disease and critical care technologies in Japan, collaborating closely with cross-functional teams. This role requires a strong understanding of the Japan market access environment, adept communication skills, and the ability to drive impactful outcomes in a dynamic healthcare landscape.
The Product Manager will develop and implement marketing and sales strategies for clean room and life science products in Japan. Responsibilities include market analysis, pricing strategy, product launches, promotions, and collaboration with key stakeholders.
You will oversee the Company's Diagnostic Solutions Global Service & Training (GST) function in Japan, ensuring high-quality service and support to customers on all Company's systems and instruments. This role involves leading and mentoring a team, managing day-to-day operations, and maintaining compliance with company standards and protocols.
Reporting to the Japan GM, lead in QA activities for the business to ensure effective compliance. Act as hinseki for the business.
Responsible of quality improvement and compliance activities to ensure effective products locally. Lead a small team of QA members to ensure effective performance.
Take lead in ensuring effective quality compliance of clinical trials being conducted overseas. Review materials, data, and other documents to align GCP.
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