Work Schedule

Environmental Conditions

Job Description

Essential Duties and Responsibilities

Understand key business drivers and leverage knowledge of the regulatory framework and environment in Japan to propose regulatory solutions that enable the delivery of products and services in the Japanese market. Lead and support regulatory-compliant procedures and preparations, and collaborate with cross-functional teams to ensure prompt resolution of issues related to post-market activities, including recalls and Field Safety Notices (FSNs), while effectively engaging with regulatory authorities and customers.

Scope of Products

Products imported and distributed by Thermo Fisher Diagnostics K.K. (TFD), including:In vitro diagnostics (IVDs), Medical devices, Research-use reagents and consumables

Product portfolio includes:

• Allergy-related products
• Autoimmune disease-related products,
• Biomarker-related products
• Quality control products,
• Protein diagnostics products
• Microbiology-related product

Key Responsibilities

• Develop and execute regulatory strategies aligned with business plans, including risk assessment of products and services under development, to accelerate product development while ensuring compliance with Japanese regulations.
• Establish and maintain timely communication with domestic and international stakeholders to obtain critical information required for regulatory submissions.
• Provide guidance, mentorship, and motivation to team members; negotiate with internal and external stakeholders when necessary.
• Collaborate with the Head of Quality Operations in Japan, Safety Officer, and other relevant stakeholders to ensure timely and appropriate resolution of product-related recalls and FSNs.
• Prepare (or supervise the preparation of) and review regulatory submission documents and labeling materials (e.g., package inserts, labels) for IVDs and medical devices in compliance with the PMD Act and related regulations.
• Ensure timely renewal and maintenance of licenses, registrations, and approvals.
• Communicate effectively with regulatory authorities (e.g., MHLW, PMDA, certification bodies, prefectural governments, public health centers), monitor review processes, and facilitate efficient regulatory submissions and approvals.
• Manage product change control processes, assess regulatory impact, communicate with stakeholders, and ensure readiness for implementation.
• Provide regulatory strategic input during protocol development for clinical studies conducted in Japan.
• Collaborate with QA to support inspections and audits by regulatory authorities (QMS).
• Contribute to the development and implementation of solutions for cross-functional operational challenges beyond regulatory scope.
• Monitor regulatory changes, assess their business impact, and propose and implement necessary actions to ensure compliance.

Required Skills and Qualifications

• Strong team management and leadership skills

• Excellent communication skills with both domestic and international stakeholders
• Ability to plan, prioritize, and manage multiple tasks effectively
• In-depth knowledge of the PMD Act (Pharmaceutical and Medical Device Act)
• Ability to accurately interpret and summarize study reports
• Knowledge of relevant laws and guidelines (e.g., Poisonous and Deleterious Substances Control Act, Industrial Safety and Health Act, PRTR/SDS regulations, ethical guidelines)
• Comprehensive understanding of regulatory affairs theories, principles, and past case precedents