RA Consultant for medical device

仕事内容

?	Local legal entity registration
?	Transfer ownership of existing product licenses from the current company to new one, per project plans
?	Submit and gain approval for company name change for all products, per project plans
?	Complete all activities to gain new product approvals and product changes:
o	Identify reportability for changes and regulatory strategy for new products
o	Prepare new product or product change submissions, based on EU or US product submission materials
o	PMDA advisory meetings
o	Manage deficiency responses, working with legal manufacturer
o	Communicate updates with legal manufacturer
?	Ensure proper IFU and product labels
?	Review and approve promotional material
?	Provide regulatory guidance on over-labeling by local office
?	Ensure license renewals and maintain license documentation
?	Support MDSAP audit preparation by collecting documents and responding to questions
?	Monitor and communicate changes in local regulations and impact
?	Availability for twice/month meetings, aligned with EU time

事業内容

オリックスグループの所有するビジネスホテル・旅館・ 研修施設の運営

必要な経験・能力

【必須】
・ホテルのファシリティ経験、あるいはホテルの現場経験と本部側業務の経験のある方

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