Impress employers and recruiters.
Choose from hundreds of resume examples.

Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

About the Role

This role is crucial for ensuring regulatory compliance and enabling the delivery of products and services in the Japanese market. You will lead and support regulatory-compliant procedures, collaborate with cross-functional teams, and engage with regulatory authorities and customers to resolve post-market issues.

Responsibilities

• Develop and execute regulatory strategies aligned with business plans, including risk assessment of products and services under development.
• Establish and maintain timely communication with domestic and international stakeholders to obtain critical information for regulatory submissions.
• Provide guidance, mentorship, and motivation to team members; negotiate with internal and external stakeholders.
• 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 and review regulatory submission documents and labeling materials 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, 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.

Requirements

• 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.

Skills

• Team management
• Leadership
• Communication (domestic and international)
• Planning
• Prioritization
• Task management

Location

• Japan

Work Type

• Office
• Warehouse
• Standard (Mon-Fri)

About the Company

• Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion.
• 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, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.

Equal Opportunity

• 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.
• 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.