RAQAディレクター/ RAQA Director

An international medical device company is seeking an experienced RAQA Director. The successful candidate will develop regulatory strategies, oversee product registrations and quality management systems, lead audits and post-market activities, and collaborate with regulatory authorities, business leaders and global headquarters to support product commercialisation.

Responsibilities:

• Lead regulatory affairs and quality assurance activities in Japan
• Develop regulatory strategies and oversee product registrations and lifecycle management
• Ensure compliance with PMDA, MHLW, QMS Ordinance and applicable Japanese regulations
• Maintain and improve Quality Management Systems (QMS)
• Lead audits, inspections, corrective and preventive actions (CAPA), complaint handling and post-market activities
• Partner with commercial teams to support product launches and business growth
• Act as the primary contact for regulatory authorities and external stakeholders
• Collaborate with Japan leadership and global headquarters to drive regulatory and quality excellence

Requirements:

• Bachelor’s degree or above in Life Sciences, Engineering, Pharmacy or a related field
• More than 10 years of experience in regulatory affairs and quality assurance (RAQA) within the medical device industry
• Strong knowledge of PMDA, MHLW, QMS and Japanese medical device regulations
• Leadership experience managing regulatory and quality functions
• Fluent level Japanese; business level English

About the Company:

A global medical technology company developing and commercialising innovative medical devices across specialties including cardiovascular care, orthopaedics, surgery and other clinical applications. Employees benefit from career growth, professional development and opportunities to support healthcare innovation and improve patient outcomes within an internationally connected workplace.

Keywords:

薬事, 品質保証, RAQA, 医療機器, 手術支援ロボット, 厚生労働省, 医療機器規制, 製品登録, 市販後安全管理, 求人, 外資系

Job Ref: 00POH0