Great RA Head opportunity for a talented RA Director / Sr. Manager interested in international position based in Tokyo for an innovative Start-up Medical Device/IVD/Oncology Company.
RA Director will develop and implement regulatory strategies that insure the approval of well-designed, high-quality medical devices/in vitro diagnostic tests.
- Provides strategic input and technical guidance on regulatory requirements to the Regulatory Affairs team members and R&D project teams.
- Anticipates regulatory obstacles and emerging issues throughout the medical device product development lifecycle and develops solutions with other members of regulatory and related teams.
- Interprets PMDA/MHLW medical device regulations, other global regulations and provides guidance to project teams
- Leads regulatory policy decisions, guides and oversees preparation of documentation for regulatory government submissions for approvals and device licenses.
<Rewards & Benefits>
- Competitive salary package and bonus system
- Being able to work with very innovative products and the best people in the industry
· Advanced degree (e.g. M.Sc., Ph.D., M.D., Pharm.D.) in the Biological, Medical, Law, Chemical or Engineering field.
· Regulatory Affairs Certification preferred
· Minimum of 10 years of medical device / pharmaceutical / biologics development experience in regulatory environments, including leadership and/or senior consulting experience.
Are you ready for a new adventure as a RA Director at an exciting Start-up Medical Device/IVD Company? Please kindly apply or call Monika Ambroziak (03 4520 4041)
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