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Director, Regulatory Affairs for Product Quality Assurance and Medical Affairs

オリンパス株式会社

  • Engineering
  • English
  • R&D
  • Quality Assurance
  • Regulatory Affairs
  • Japanese
  • Medical
  • Compliance
  • Science
  • Product Lifecycle Management
  • Regulatory Agencies
  • Regulatory System
  • Global Company
  • Matrix Organization
  • Regulatory Approvals
  • Notified Bodies
  • Global Markets
  • Regulatory Filings
  • Global Regulatory Strategy
  • Medical Device Industry
  • Salary ⁨¥⁩⁨13,000,000⁩ - ⁨20,000,000⁩
  • Work Location Tokyo
  • Company employee count 1,001 to 10,000

Company Info

Orinpasu is an IT infrastructure and application development service provider, implementing comprehensive control technology, information technology operation, server system, cloud security, cloud system, and cloud security to support businesses worldwide. In addition, the company is based on the principles of empathy, realism, innovation, implementation, and inclusiveness, promoting cultural implementation.

Job Summary

In this position, you will be responsible for living the regulatory experience in the medical device industry, developing and implementing new product market entry strategies, defining the overall regulatory strategy for the entire product lifecycle, coordinating with regulatory authorities, managing product regulatory team, and a wide range of business activities are required. In addition, experience in regulatory recognition of medical devices and management of product lifecycle management is required.

Duties

This position is responsible for the development and maintenance of products, as well as the implementation of global regulatory strategies and practices to support business activities, and the maintenance of product registrations worldwide. In addition, it is necessary to provide comprehensive support for the expansion of domestic and international markets, and to provide the necessary regulatory development, strategy, and management for product registration worldwide, in order to achieve the overall QARA goals of Olympus. In addition, it is necessary to provide necessary regulatory activities, strategies, and management for the expansion of domestic and international markets, and to provide necessary support for the growth of the company.

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Director, Regulatory Affairs for Product Quality Assurance and Medical Affairs

オリンパス株式会社

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