【東京】Director, Regulatory Affairs

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Job details

Company overview

We specialize in the development, manufacturing, and distribution of medical and scientific equipment. We are particularly renowned for our expertise in fields such as endoscopy and digital camera technology. We prioritize quality and innovation in our products, playing a crucial role in the medical and research sectors. Furthermore, we tailor solutions to meet the needs of our customers, providing support to medical and research institutions worldwide.

Responsibilities

【変更の範囲：会社の定める業務】

• The Executive Director Regulatory Affairs is responsible for leading the development and execution of the global regulatory strategy for new product development and sustaining projects, the management of all regulatory activities in support of the business units, maintaining product registrations globally throughout product lifecycles.
• The position is responsible for developing and executing regulatory strategies to support corporate growth objectives for the business by providing guidance, strategy and management of regulatory activities needed for domestic and international expansion.
• The position requires strategic partnership with the cross functional business leaders for the strategy of introducing new devices to global markets.
• This role requires interaction with global regulatory agencies and notified bodies.

Requirements

• 医療機器業界における薬事業務経験（15年以上）
• 英語および日本語での文書および口頭でのコミュニケーションスキル
• TOEIC: 800

Salary

13 - 20 million yen

Location

Tokyo