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Philips Regulatory Affairs Senior Manager - Japan, Chiyoda 891610037
24.06.2024
Regulatory Affairs Senior Manager - Japan
- 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 productregistration/reimbursementdocument.
- Proceed regulatory assessment and promotional material review.
- Oversee product registration and RA administration activities.
- Drive varioustransformation/improvementactivities.
- +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.
- Self-motivated and able to prioritize to handle multipletasks/responsibilities.
- Bachelor of Science Degree (Master preferred)
- Fluent in Japanese and English
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