Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

Job Summary

Join Thermo Fisher Scientific Diagnostics K.K. as an extraordinary Regulatory Affairs Specialist II, an outstanding opportunity to contribute to our world-class Regulatory Affair team in Japan. You will be instrumental in ensuring that our innovative products and services meet the highest standards of safety and compliance, helping us make a global impact.

Job Responsibilities

• Provide expert advice and suggestions to ensure new products, services, and activities comply strictly with national regulations.
• Plan and successfully implement regulatory strategies based on project plans.
• Communicate regularly with collaborators both internationally and domestically to acquire essential information for pharmaceutical applications.
• Prepare and review registration documents and labeling materials for in vitro diagnostics and medical devices.
• Undertake updates and changes to relevant licenses in a timely manner.
• Consult with regulatory authorities (MHLW, PMDA, certification bodies, prefectures, public health centers) as necessary.
• Advise on pharmaceutical strategies for clinical research, confirm data, and support ethical reviews.
• Collaborate with QA teams to respond to QMS auditing by authorities.
• Maintain and continuously improve processes to ensure compliance with regulatory standards.

• Proven ability to connect effectively with Japanese and foreign peers.
• Ability to plan multiple tasks and prioritize activities flawlessly.
• Detailed understanding of the Pharmaceutical and Medical Devices Law.
• Competence in accurately understanding and compiling test reports.
• Proficiency in reading and writing English for international communication.
• Familiarity with other essential laws and guidelines (Poisonous and Deleterious Substances Control Act, Industrial Safety and Health Act, PRTR-SDS Act, Ethical Guidelines, etc.).