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| 部署・役職名 | Quality Assurance ＆ Regulatory Affairs Manager |
|---|---|
| 職種 | |
| 業種 | |
| 勤務地 | |
| 仕事内容 |
This position is a senior leadership role that oversees both regulatory affairs and quality assurance for a global dental company in Japan. You will act as the legally responsible manager to ensure all medical devices and products meet strict government standards. By leading the local quality team, you will serve as the main link between the Japan office and the international headquarters. Responsibilities: － Serve as the legally designated manager responsible for product quality and regulatory compliance in Japan. － In charge of ensuring all operations follow ISO 13485 standards and local medical device laws. － Manage the quality department and communicate regularly with global offices regarding safety and regulations. － Oversee product inspections, market release approvals, and the management of all shipping documents. － Coordinate with government authorities during audits and manage all necessary business licenses. |
| 応募資格 |
【必須（MUST）】 － Licensed pharmacist or have a university degree in chemistry or pharmacy.－ 5＋ years of experience in medical device or pharmaceutical industry. － Proven track record in quality assurance and regulatory affairs. － Business－level English skills to write documents and speak with global headquarters. 【歓迎（WANT）】 － Bachelor’s degree or higher in a scientific field is highly desired.－ Previous experience specifically within the dental equipment or dental materials industry is a plus. － Extensive knowledge of international quality standards like ISO 13485 is preferred. |
| リモートワーク | 可 「可」と表示されている場合でも、「在宅に限る」「一定期間のみ」など、条件は求人によって異なります |
| 受動喫煙対策 | 屋内禁煙 |
| 更新日 | 2026/02/03 |
| 求人番号 | 6874681 |
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転職・求人情報の詳細をご覧になる場合は会員登録（無料）が必要です