Auditor and Product Specialist for Medical Devices

hace 1 semana


Barcelona, Barcelona, España Tuv Rheinland A tiempo completo

Job Summary

We are seeking a highly skilled Auditor and Product Specialist to join our team at TUV Rheinland. As a Product Expert, you will be responsible for evaluating IVD medical products in accordance with European guidelines and standards.

Key Responsibilities

  • Evaluate IVD medical products in accordance with European guidelines and standards
  • Review technical documentation of selected product groups in non-active products area
  • Assess sterilize and non-sterilize devices, including implantable devices such as orthopedic and dental implants, mesh and instruments
  • Collaborate with cross-functional teams to ensure compliance with regulatory requirements
  • Develop and maintain knowledge of relevant guidelines, norms, and product specific standards

Requirements

  • Degree course in Natural Sciences/Biology, Biotechnology, Biomedical Engineering
  • At least 4 years professional experience in design & development, production, quality assurance, regulatory affairs or quality management of medical devices (related to IVD)
  • Fluent in Spanish and English; Portuguese is a plus
  • Local and international business trips are required (depending on job position focus as Auditor and/or Product Expert 20 to 50% per month)

What We Offer

  • Stable job with an open-ended contract
  • Training provided by the company
  • Salary to be agreed


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