30+ days ago - req22060

Regulatory Compliance engineer

Research & development

Other technical job categories

In a nutshell

Location

Veldhoven, Netherlands

Team

Research & development

Experience

3-7 years

Degree

Master

Job Category

Other technical job categories

Travel

10%

Introduction

Within global product safety we have to ensure that ASML is developing products that comply to regulations and customer requirements. To achieve this goal, the global product safety team defines design requirements to enable designers in developing safe & compliant products.

Job Mission

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.