【1020～1440万円】Senior Regulatory Affairs ManagerーIGTD

【求人No NJB2210881】
Exciting opportunity to lead Cardiac and Endovascular projects of Philips Image guided Therapy including novel technologies integrated by therapeutic devices and visualization systems.

・Develop local regulatory strategy and lead the strategic discussion with related stakeholders including Business Unit R D Clinical Affairs and Market Access Reimbursement to accelerate projects and fast serve patients.
・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 and technologies relevant to endovascular therapeutics.
・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.

1. Experience.
+10 years’ experience in medical device regulatory affairs
Actual experience of authoring Class III/IV medical device SHONIN submission in EVT or relevant devices and received approval.
Maintains extensive knowledge of PMD act ISO 13485.
Experience or working knowledge of active medical devices and imaging technologies.
Capable of resolving escalated issues arising from day to day operation.

2. Skills.
Self motivated and able to prioritize to handle multiple tasks/responsibilities.
Bachelor of Science Degree （Master preferred）
Fluent in Japanese and English