募集要項
- 募集背景
- An RA Specialist position is now available at a multinational medical device company. The applicant chosen for this role will be accountable for obtaining regulatory approvals for the sale of various medical products.
- 仕事内容
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An RA Specialist position is now available at a multinational medical device company.Responsibilities:
* Share regulatory expertise with cross-functional teams to facilitate NPI processes
* Define QMS and regulatory requirements
* Create and execute strategies to ensure successful product launch
* Ensure proper documentation of labelling evaluation and approvals
* Align product labels with corporate standards and local regulations
* Provide support in maintaining and enhancing regulatory and development procedures
Requirements:
* 3+ years of regulatory affairs experience for medical devices (class II+)
* Previous experience liaising with PMDA or notified body reviewers
* Expertise in QMS accreditation and ISO 13485 requirements
* Working knowledge of surgical devices is ideal
* Excellent PC skills to handle regulatory datasets
* Written and verbal English proficiency
- 応募資格
-
- 必須
- Previous experience liaising with PMDA or notified body reviewers
- 歓迎
- 英語力必要。その他は詳細からご確認ください。
- 雇用形態
- Permanent
- 勤務地
- Tokyo
- 年収・給与
- JPY7,000,000.00 - JPY9,000,000.00 per annum
- 休日休暇
- 完全週休2日制, 土日祝日休み, 有給休暇