Regulatory Compliance Specialist - Electrical Safety & EMC

IBA Worldwide

  • Louvain-la-Neuve, Waals Brabant
  • Vast
  • Voltijds
  • 7 dagen geleden
Mission
  • Ensure that the requirements from applicable technical standards and technical regulations are correctly interpreted as inputs for development, for test methods and for processes
  • Act as IBA tester for conformity to electromechanical and EMC safety standards and lead negotiations with external laboratories to support accredited testing
  • As a referent expert, take the lead of the interpretation of requirements from standards and technical regulations.
  • Hold a cross-disciplinary look to deal with complex questions regarding the provided technical solutions
Challenges we trust you with
  • Ensure consistency in IBA development projects between requirements from technical standards and regulations and design inputs, test methods and impacted processes.
  • Stay up-to-date on regulatory changes and standards to suggest methodologies, compliance framework and standards
  • Coach and train development Engineers and Physicists on compliance
  • Maintain rules, processes and best practices of IBA internal accredited laboratory.
  • Interface externally with accredited laboratories and key opinion leaders in standardization
What we value
  • A Master degree in (Engineering) Industry, Mechanics or Electromechanics
  • Ideally 4 years or more of hand-on in highly regulated industries are desirable
  • Knowledge of electrical safety based on IEC/EN 60601-1 (Medical Electrical Equipment) or on equivalent is an asset (for example IEC/EN 60204-1 -Safety of machinery, IEC/EN 61010-1 electrical equipment for measurement, control, and laboratory use).
  • Knowledge of Electromagnetic compatibility (EMC) based on IEC/EN 60601-1-2 ("Medical Electrical Equipment-Electromagnetic disturbances"), or on equivalent is an asset (for example IEC/EN 61000-4-x family, IEC/EN 61326-1 product family).
  • Understanding of regulated quality management systems, good documentation practices, are an asset.
  • Experience in electronic design and simulation is a plus.
  • Good communication skills in English
  • Knowledge of French is an asset
And you also are:
  • Able to research and develop a critical analysis of information
  • Able to produces a range of workable solutions to problems
  • Fascinated by new technologies and always willing to update your knowledge
  • Hands-on, driven and proactive
  • Structured and rigorous and able to organize your work autonomously
  • An assertive team player with good interpersonal skills
  • Ready to travel 10% of your time
Cherry on the cake
  • Experience with medical devices
  • Experience with accredited laboratory
  • Negotiation skills

IBA Worldwide