Product Safety and Regulatory Engineer

Introduction to the job

The company is developing advanced technology products in worldwide. Through that case, it is important to comply with local specific regulations when business is realized. The person who charged in this position, he/she needs to research local regulations and provide the latest information to development team to avoid in-compliance condition before releasing of products in the field. In parallel, he/she needs to handle customer inquiries to fulfill customer satisfactions. This activity is supporting to boost up overall businesses.

Role and responsibilities

• Maintain Japan local compliancy table (applicable local regulations for all ASML/HMI products)

  • Previous local application data (EUV, DUV etc…)

  • Safety Label Information

  • Applicable CSR

  • Applicable laws for import parts

• Updates local compliancy information upon configuration changes and regulation changes.

• Support Japanese key book regulatory proof review, training slides etc…, in cooperation with VHN competence team and BL team.

• Manage local regulatory standard, formats, local authority inspection data, training, SOPs etc…, data filing.

• Coordinate local application registration dossiers (includes application form, product review evidence, product overview etc…).

• Regulatory support for R&D, BL, Legal and account team.  Monitor and report on relevant changes to regulations and impact for ASML (product/complaint/technical compliance approval).

• Attends relevant projects and process meetings as requested.

Education and experience

Bachelor

4-9 years working experiences are required.

Skills

Frequent Japanese/English speaker.

Project management experiences are +.

This position requires access to controlled technology, as defined in the United States Export Administration Regulations (15 C.F.R. § 730, et seq.). Qualified candidates must be legally authorized to access such controlled technology prior to beginning work. Business demands may require ASML to proceed with candidates who are immediately eligible to access controlled technology.

Inclusion and diversity

ASML is an Equal Opportunity Employer that values and respects the importance of a diverse and inclusive workforce. It is the policy of the company to recruit, hire, train and promote persons in all job titles without regard to race, color, religion, sex, age, national origin, veteran status, disability, sexual orientation, or gender identity. We recognize that inclusion and diversity is a driving force in the success of our company.

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