メディカル・バイオ - 薬事申請

Exciting opportunity to play an integral role in introducing new product/solution, maintain regulatory compliance and leading transformation/improvement activities.

・Develop local regulatory strategy and lead the strategic discussion with related stakeholders to accelerate project development.
・Proactively identify risks within regulatory strategies, plans, products and propose alternate approaches.
・Plan and execute product registration aligned with local business needs.
・Maintain current registration approvals accordingly.
・Manage interactions with MHLW/PMDA and maintain a productive working relationship.
・Review/Author product registration document, QMS/FMR document and reimbursement document.
・Proceed regulatory assessment and promotional material review.
・Supervise RA administration activities.
・Lead various transformation/improvement activities.

■休日：完全週休二日制, 土, 日, 祝日, 年末年始

1. Experience.
・+7 years’ experience in medical device regulatory affairs
・Experience or working knowledge of applicable standards/guidelines including software development lifecycle, risk management and cybersecurity in medical device.
・Maintains general knowledge of PMD act, ISO 13485, Radio act and Measurement act.
・Actual experience of authoring class III / IV medical device submission including SaMD and received approval.

2. Skills.
・Self-motivated and able to prioritize to handle multiple tasks/responsibilities.
・Bachelor of Science Degree in a regulatory or technical discipline (Master's preferred)
・Fluent in Japanese and English

■職種未経験者：不可