Regulatory Compliance Specialist - Electrical Safety & EMC

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