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|Regulatory Affairs Sr. Specialist／外科手術製品|
|業務内容||-obtain and understand technical documents for registration through correspondence with Medtronic global RA.
-Organize and prepare registration document in Japanese.
-Submit registration document to authorities.
-Prepare answer to inquiries from authorities with the support from global RA.
-Collaborate with other department in Japan and global RA to discuss regulatory strategy.
-Review change control information and assess regulatory impact
-Understand PAL regulations, MHLW requirements and standards.
-Attend necessary trainings and seminars to keep abreast of new and/or changes in the Regulatory requirements
|経験・知識||Experience : At least 6 years registration experiences in medical device.
Skills/Competencies: Good understanding for regulations and registration guide
Strong PC skill
Education : Bachelors Degree in scientific discipline or equivalent experience.
Japanese: Excellent written and oral communication skills
English: Good at English, including reading, writing, and speaking
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