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.
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.
Technical Master degree or Bachelor with equivalent work experience
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
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.