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REGULATORY EXPERT, FOR MEDICAL ACTIVE DEVICES

Descripción de la oferta de empleo

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: Degree in Electrical/Electronic/Biomedical Engineering or similar Knowledge of and familiarity with Medical Devices Regulation (MDR) (UE) 2017/745 Demonstrable knowledge of most relevant active medical device's standards, like i.e. series IEC 60601-1-X, 60601-2-X, IEC 62366, ...., and, generally, on most demanded products / collateral standards High communications skills and capabilities to transmit goals and indications, quickly and efficiently What do we offer? Fulltime contract (onsite or hybrid) Salary according candidate experience 23 days of vacation + 3 free disposal days Flexible remuneration plan (medical plan, restaurant, kindergarten, transportation) Canteen with reduced price Employee parking Language courses
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Detalles de la oferta

Empresa
  • Applus+ Laboratories
Localidad
  • En toda España
Dirección
  • Sin especificar - Sin especificar
Fecha de publicación
  • 08/01/2025
Fecha de expiración
  • 08/04/2025
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