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.
Provide interpretation of local regulations to BU partners and ensure necessary requirements are fully deployed.
Stay informed of new regulations such as mobile monitoring, clinical decision support and AI.
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 and Author product registration/reimbursement document.
Proceed regulatory assessment and promotional material review.
Oversee product registration and RA administration activities.
Drive various transformation/improvement activities.
+10 years’ experience in medical device regulatory affairs
Actual experience of authoring medical device SHONIN submission including SaMD and received approval.
Maintains extensive knowledge of PMD act, ISO 13485, Radio act and Measurement act.
Experience or working knowledge of applicable standards/guidelines including software development lifecycle, cybersecurity, clinical decision support in medical device.
Capable of resolving escalated issues arising from day-to-day operation.
2. Skills.
Self-motivated and able to prioritize to handle multiple tasks/responsibilities.