Job Description

Key Responsibilities

• Lead the incorporation process for the company’s legal entity in Japan, working with local authorities, legal firms, and stakeholders to ensure smooth setup.
• Conduct  market research and competitive analysis to identify potential IVD products with high market potential for registration and distribution in Japan.
• Coordinate the  end-to-end medical product registration process with PMDA or other relevant regulatory bodies.
• Identify, evaluate, and negotiate with potential  distribution or partnership companies in Japan for medical product sales.
• Act as the primary  liaison between headquarters and Japanese stakeholders , ensuring alignment on strategic goals and execution.
• Monitor project timelines, budgets, and deliverables to ensure timely and successful outcomes.
• Prepare and present periodic updates to senior leadership on project progress, risks, and recommendations.

Requirements

Qualifications

• Bachelor’s degree or above in  Biomedical Science ,  Biotechnology ,  Pharmaceutical Sciences , or related fields.
• Minimum of 3 years’ experience in project management, regulatory affairs, or market entry roles within the  medical device or IVD industry .
• Proven experience in  medical product registration processes in Japan (knowledge of PMDA regulations is an advantage).
• Strong understanding of Japan’s  IVD market , business environment, and local healthcare system.
• Native-level Japanese proficiency is required. Ability to communicate fluently in  Mandarin or English is also essential.
• Excellent interpersonal, organizational, and negotiation skills.
• Ability to work independently in a fast-paced, cross-functional environment.

Preferred Skills

• Familiarity with  Japan’s medical device regulatory framework and distributor networks.
• Experience working in or with  multinational life science or diagnostics companies .
• Prior involvement in  company incorporation or market entry projects in Japan.

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