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- Cross-functional position.
- Amazing career path and professional growth.
About Our Client
Our client brings together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases. Headquartered in the US, our long standing history client have provided excellent solutions taking care of the people health.
Job Description
* Initiate NPI submission strategy, planning (MHLW, TUV, WHO, others)
* Develops registration plans for assigned products in collaboration with regional Regulatory Affairs based staff and manufacturing site cross functional colleagues (QA, Supply Chain, Operations, etc)
* Participate design change project and provide the status update to cross functional colleagues (R&D, Tech Support, QA, Supply Chain, Operations, etc)
* Ensures execution of registrations of products in alignment with regulatory plans.
* Actively participates in short and long-range planning including the development of Key Performance Indicators
* Promotes awareness of regulatory and customer requirements throughout the organization, including through organized training programmed.
* Directly manages registration activities with Notified Bodies in Europe and the WHO.
* Supports sites in contact with National Regulatory Agencies.
* Represents manufacturing site as RA responsible at relevant leadership meetings.
The Successful Applicant
* Bachelors degree and training in Regulatory Affairs.
* A minimum of 5 years experience in areas directly relevant to the position.
* Japanese/English Business level.
What's on Offer
* Possibility to work with multidisciplinary teams.
* Attractive salary package.
