規制事務専門員/ Regulatory Affairs Specialist

A global medical devices company is looking for a Regulatory Affairs Specialist. The selected candidate will handle product approvals and regulatory submissions in Japan. This is a remote role.

Responsibilities:

• Acquire and update product approvals in Japan
• Lead consultations with Japanese regulatory authorities
• Manage change controls in collaboration with QA for software updates
• Prepare and consult on Shonin dossier submissions to PMDA
• File notifications for minor changes
• Support acquisition of Shonin, Ninsho, and Todokede approvals

Requirements:

• Experience with regulatory affairs
• Prior experience with acquisition of Class 3 or higher medical devices
• Proven experience with medical software is ideal
• Background in an international setting is a plus
• Understanding of Japanese medical regulations and applicable standards
• Proficient with MS Office Suite

About the Company:

A global leader in oncology software, this company develops innovative solutions to improve cancer treatment planning and delivery. With a strong focus on research and development, it collaborates with leading cancer centers worldwide to advance precision medicine in radiation therapy.

Keywords:

製薬, メディカル, サイエンス, 求人, 外資系

Job Ref: 7SX2ZY