Regulatory Affairs Manager

【求人No NJB2214555】
Your role:

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 and reimbursement document.
・Proceed regulatory assessment and promotional material review.
・Supervise RA administration activities.
・Lead various transformation/improvement activities.

1. Experience.
・+7 years’ experience in medical device regulatory affairs
・Maintains general knowledge of PMD act ISO 13485 Radio 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 technical discipline （Master's preferred）
・Fluent in Japanese and English