Regulatory Compliance engineer
ASML
Veldhoven, Netherlands
3 dagen geleden

To ensure Product Safety requirements are in line with the latest legislation, standards and guidelines, a Product Safety regulatory & compliance office has been set up to support the global product safety team and facilitate product regulatory board decisions.

As a member of the Product Safety regulatory & compliance office you manage and optimize the processes and organize the office (team) to support ASML’s success on the international market.

Job Description

As a Product Safety regulatory & compliance engineer you are expected to :

  • Build & support an international Notified Body network within the strategic countries where ASML ships its products;
  • Work in close cooperation with Global Product Safety managers to interpret & assess (branch) guidelines impact to ASML legal new product compliance position;
  • Manage the intake of new legislation, standards and guidelines : use IT tooling to identify upcoming changes, process incoming information from external organizations;
  • Consult frequently with Global Compliance on impact assessment of changes in the regulatory landscape ensuring alignment with corporate policies;
  • Manage the impact assessment process of changes in new legislation / standards for ASML, prepare the impact analysis for the regulatory board;
  • Manage the change requests for Product Safety Requirements documentation based on changes in legislation, standards and guidelines, and manage the progress of the changes + reporting;
  • Create and manage inventory of Standards & Regulations related to product safety in ASML database;
  • Support Product Safety community within ASML to carry out research via third parties;
  • Own overall compliance qualification processes to create cross-cluster compliance documents according to regulatory and customer requirements;
  • Support cross-cluster compliance teams to execute compliance qualification process and generate regulatory and customer compliance documents;
  • Create and maintain repository of all regulatory certificates, declarations, test reports as well as customer compliance reports;
  • Track and trace identified compliance issues for new products across different business lines;
  • Support in realizing the implementation (release) plan of the Safety requirements documentation;
  • Support & process safety information requests both from internal customers as well as external organizations (e.g. customer requirements) : e.
  • g. share compliance reports and administrate the communication;
  • Build and maintain network across local ASML teams in different countries;
  • Facilitate escalation process in case of non-compliance situation.
  • Education

    Technical Master degree or Bachelor with equivalent work experience

    Experience

  • Extensive (>
  • 5 years) experience in international Regulatory / Compliance processes & organizations

  • Experience working with senior level decision makers
  • Legal) experience with machine development processes with new fundamental technologies

  • Proficient in the English language (Korean / Cantonese language is pre)
  • Product legal compliance experience
  • Personal skills

  • Strong international networker
  • Able to set up new international contacts in US / Asian countries
  • Willing to travel intercontinentally on a regular basis
  • Able to work independently
  • Meticulous in data management / record keeping
  • Self-structured and organized
  • Conscious in working with strictly confidential information
  • Delivers high quality, focuses on process compliance
  • Remains persistent until the goal has been reached
  • Takes responsibility for timely delivery of content; drives creators and users to deliver according to plan.
  • Coaches colleagues on the processes
  • Context of the position

    You will report to the group lead of the Safety and Compliance group within our Quality department.

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