SR RA Manager

Your New Career Opportunity

Specialized Group is currently in search for a SR RA Manager in Tokyo.

Our Client

Our client is a global top of the line Medical Device company headquartered in the US that develops, manufactures, and distributes Medical Devices and Healthcare products. They boast over 60,000 employees globally and offer a standard setting culture with high employee satisfaction. This is a great opportunity to lead a successful RA team as the client has a robust future pipeline of products that will require management throughout the approval process. 

These products range from Class II to Class IV and will further the Healthcare industry in Japan as they continue to improve the lives of the aging population. This company has a plan to surround whoever steps into this role to surround them with the right management training and culture that will facilitate growth in management abilities.

• 12-15m annual salary, 15% Bonus annually
• Great retirement package

Your Responsibilities

• Registration of medical devices and Business license maintenance 
• PMDA submission to completion of Class II, III, IV medical devices 
• Manage team of 4 
• Corresponding to the inquiries from JP authorities (MHLW, PMDA and Notified Body) 
• Establish and drive the Regulatory Affairs initiatives 
• Develop and maintain professional relationship with regulators in Japan 
• Lead GVP/QMS works in cooperation with International RA/QA team and other stakeholders 
• Maintain effective oversight of suppliers and contracts through timely review, in compliance with SOPs 

The Skills and Experience You Need to Succeed

• 5 years of Regulatory Affairs Experience 
• Native-level Japanese 
• Business-level English 
• Japan PMDA submission experience

The Benefits You Will Receive

• Top of the market salaries
• Top tier company
• Managing team
• Training