Quality Assurance/Regulatory Affairs Manager

求人詳細

Position: Quality Assurance/Regulatory Affairs Manager

About the Job:

We are seeking a QA/RA leader to oversee the quality and regulatory aspects of our innovative IVD products in Japan. The role involves maintaining a high standard of quality, managing regulatory documentation, and supporting registration processes for new and existing IVD licenses. The ideal candidate will be passionate about addressing unmet medical needs and ensuring compliance with relevant standards.

Role Description
● Ratio – QA 70% / RA 30% (RA projects to be supported by external consultant)
● Act as Document Control Center to handle all quality and regulatory documents related to applicable standard for Quality Management System.
● Prepare, register, and gather documents related to registration process to get both new and renew IVD licenses

こんな方を求めています

経験・スキル

Minimum Requirement
● Licensed pharmacist
● +3 years of experienced in QA
● Business level Japanese / Conversational English

Preferred Requirement
● Distinctive problem solving, organizational, and analytical skills
● Ability to influence multiple stakeholders without direct authority
● Experience in IVD/ Medical device

学歴

大学卒業以上

募集要項

職種

安全性管理、品質保証、品質管理

給与

年収 700 〜 800万円

賞与

Variable

雇用形態

正社員

雇用期間

期間の定めなし

就業時間

09:00～18:00

休日休暇

土曜日　日曜日　祝日

保険

健康保険　厚生年金保険　雇用保険,健康保険

受動喫煙防止措置

敷地内禁煙

特長

外資系企業, ベンチャー企業, 土日祝休み, 完全週休2日制, 語学力を活かす

業種

医療機器・医療品関連

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