Regulatory Expert, for Medical Active Devices

Applus+ Laboratories has a network of laboratories across Europe, North America and China, and more than 30 years under its belt of testing and certifying electrical and electronic products and devices for a range of industrial applications.

Applus+ Laboratories works together with manufacturers of electrical and electronic products and devices, helping them to enhance product competitiveness and gain the necessary international certifications to achieve Global Market Access.

In the Electrical and Electronics Business Unit, we are currently looking for Regulatory Expert, for Medical Active Devices, to join our team and help us to grow within the testing and certification services for active medical devices.

This position is ideally thought for Barcelona, however other locations could be analysed depending on the candidate.

Your responsibilities will be :

• Increase current ISO17025 accreditation scope for testing capabilities related to active medical devices standards
• Define the strategy and timing for the plan implementation and execute it accordingly
• Review technical standards and perform gap analysis focused on optimization of assets and synergies among active medical standards / devices
• Define requirements for the qualification of the technical staff to perform the activities as well as procedures to keep the personnel trained
• Analyse the usability of the active medical device under evaluation and related data, as well as set the definition of the Test Plan for a certain active medical device.
• Identification and evaluation of the risks associated with the use of the medical active device under evaluation, defining testing methods, goals and criteria for mitigation
• Detect needs of new equipment or trainings
• Communicate and coordinate the activities with the Laboratory / Operations Manager

We are looking someone with :

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