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About the Role

This role is responsible for quality assurance of research equipment (including consumables) and reagents. As a specialist in Regulatory Compliance for our products, you will primarily confirm various regulations (poisons and hazardous materials, Cartagena, etc.) during new product introductions, handle necessary administrative tasks, and create legal labels and SDS. You will also respond to internal and external requests, primarily focusing on customer support.

Responsibilities

• Quality assurance of research equipment (including consumables) and reagents.
• Regulatory Compliance specialist for company products.
• Confirming various regulations (poisons and hazardous materials, Cartagena, etc.) during new product introductions.
• Handling necessary administrative tasks for new product introductions.
• Creating legal labels and SDS (Safety Data Sheet).
• Responding to internal and external requests, primarily customer support.
• Investigating domestic product regulations (e.g., Industrial Safety and Health Act, Poisonous and Deleterious Substances Control Act, PRTR Act, Electrical Appliances Safety Act (PSE), Radio Act, High Pressure Gas Safety Act, etc.) for self-produced products and managing databases.
• Creating/revising GHS labels and SDS (Safety Data Sheet).
• Handling customer inquiries.
• Issuing certificates.
• Conducting training and business support activities.
• Improving processes for regulatory compliance.
• Managing business operations (e.g., "Poisonous and Deleterious Substances Importer/Distributor").
• Product management as a certified handler of poisons and deleterious substances, and maintaining business permits.
• Creating training materials and conducting internal training.

Requirements

• Must meet the qualification requirements for a certified handler of poisons and deleterious substances.
• Knowledge of and experience handling various research equipment and analytical reagents from our company, or products from other companies in the same industry.
• Ability to read and write official documents and conduct negotiations in Japanese.
• English proficiency at a level sufficient for reading technical documents and composing emails/participating in conference calls.
• More than 3 years of practical experience in product safety or chemical management at a manufacturer.
• Experience in quality assurance staff at a manufacturer's headquarters (experience in company-wide coordination, guidance to various business units, and SOP creation).
• Basic knowledge of ISO.

Skills

• Product safety
• Chemical management
• GHS labels
• SDS
• Regulatory Compliance
• SAP
• TrackWise
• SFDC
• ERP systems
• Team management
• Quality assurance

Location

• Mita Headquarters

Work Type

• Standard (Mon-Fri)
• Office
• Hybrid

Experience Level

• 3+ years of practical experience in product safety or chemical management at a manufacturer
• Team leader or team management experience

Education Level

• Bachelor's or Master's degree in science (e.g., Pharmacy, Chemistry, Biology, Microbiology, Engineering, etc.)

About the Company

• Thermo Fisher Scientific Inc. is headquartered in Waltham, Massachusetts, USA, and has over 120,000 employees worldwide.
• Annual sales exceed approximately $40 billion, with R&D expenses of approximately $1.3 billion.
• Brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD are widely used by customers in various fields worldwide, from basic and applied research, product development, quality control/assurance, and security to healthcare, pharmaceuticals, and biopharmaceuticals.
• Our Mission is to enable our customers to make the world healthier, cleaner and safer.
• We support customers in accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies.
• Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands.

Equal Opportunity

• We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
• Thermo Fisher Scientific is an Equal Opportunity Employer.
• All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.