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RAQA Specialist and Manager

Tokyo 外資系企業 Japanese Corporate View Job Description
Develop an effective regulatory strategy for each project from a broad perspective and achieve active product introduction.Proactively advance each project with skills to deliver powerful, compelling messages while maintaining good communication with various parties at BD / Medicon, MHLW / PMDA, and industries.Understand PMDA / MHLW's thinking and successfully negotiate for the benefit of BD / Medicon and projects.
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  • hybrid working arrangement.
  • Competitive salary and benefits.

About Our Client

A leading global medical technology company that creates medical technology, devices, and laboratory equipment for various needs across the healthcare sector.

Job Description

  • Develop an effective regulatory strategy for each project from a broad perspective and achieve active product introduction.
  • Develop logical thinking, simplify complex information, and provide logical explanations.
  • Proactively advance each project with skills to deliver powerful, compelling messages while maintaining good communication with various parties at BD / Medicon, MHLW / PMDA, and industries.
  • Understand PMDA / MHLW's thinking and successfully negotiate for the benefit of BD / Medicon and projects.
  • Enhance internal compliance and risk management system based on an understanding of the Japanese PMD Act and other business-related laws and regulations.

The Successful Applicant

  • Has an experience in regulatory affairs for class I / II / III / IV medical devices in a medical device company, or a Contract Research Organization (CRO).
  • Business level English.
  • Strong interpersonal skills are required in the areas of verbal and written communications, focus on regulatory bodies, appropriately responsive to service to internal business needs, coaching, influencing, and team building with a growth mindset

What's on Offer

We embrace a growth mindset, building capabilities for the future and helping you become the best version of yourself. We offer our employees a clear direction and career pathway for development. We pride ourselves on our transparent and rigorous talent processes that are inclusive, deeply embedded in trust, aligned with our culture, and enable us to achieve the strategic imperatives of the organization. Our leaders are committed, engaged, and accountable to making talent our top priority

Contact
Aiko Estrellado
Quote job ref
JN-112023-6264082
Phone number
+81 3 5733 7166

Job summary

Function
Healthcare
Specialisation
Healthcare
What is your area of specialisation?
Healthcare / Pharmaceutical
Location
Tokyo
Job Type
Permanent
Consultant name
Aiko Estrellado
Consultant phone
+81 3 5733 7166
Job Reference
JN-112023-6264082
Company Type
Japanese Corporate

Diversity & Inclusion at Michael Page

We don't just accept difference - we celebrate it. We encourage applicants from all backgrounds to apply for this role and are committed to building inclusive, diverse workplaces where everyone can thrive. If you require any support or reasonable adjustments during the recruitment process, please let us know.