Regulatory Affairs Specialist (RA) / ~8M JPY @ Global MedTech

求人詳細

Global Compliance & Change Management Lead

■About our Client
Top-tier global healthcare firm. They provide diagnostics and medical devices to improve patient care worldwide.

■Role Overview
Supports global regulatory compliance for IVD products as Legal Manufacturer. Manages international registrations, submissions, change controls, and ensures adherence to ISO 13485 QMS standards.

■Responsibilities
・Prepare global RA submissions
・Manage product change controls
・Ensure labeling compliance
・Support audits and inquiries
・Monitor global reg updates
・Cross-functional collaboration


If you are interested in this position, we look forward to your application.

#LI-Hybrid

こんな方を求めています

経験・スキル

■Requirements
・Strong English and Japanese communication skills (written and verbal)
・Experience in Regulatory Affairs for IVD or Medical Devices; typically 2+ years
preferred, but equivalent experience considered
・Ability to collaborate effectively with cross-functional teams
・Understanding of regulatory requirements for IVD/Medical Devices
・Basic understanding of ISO 13485 and global QMS principles
・High attention to detail and strong documentation management skills

■Nice to haves
・Experience in building and maintaining Technical Files (e.g., IVDR, CSDT, STED)
・Hands-on experience with international product registrations and change submissions
・Project coordination or cross-functional collaboration experience
・Familiarity with risk management principles (ISO 14971)
・Strong technical writing skills for regulatory documentation
・Ability to monitor and interpret global regulatory changes (Regulatory Intelligence)

学歴

大学卒業以上

募集要項

職種

薬事、メディカルライティング

給与

年収 400 〜 800万円

賞与

-

雇用形態

正社員

雇用期間

期間の定めなし

試用期間

有り

就業時間

08:45～17:30

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

受動喫煙防止措置

敷地内禁煙

業種

医療機器・医療品関連

※詳細はお仕事のご紹介時にお伝えします