Auditor & Product Expert For IVD Expert Devices

hace 7 días


Barcelona, Barcelona, España Tuv Rheinland A tiempo completo

Job Summary

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

Key Responsibilities

  • Evaluate IVD Expert medical products in accordance with European guidelines and standards
  • Review technical documentation of selected product groups in the non-active products area
  • Assess sterilize and non-sterilize devices, 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, or Biomedical Engineering
  • At least 4 years of professional experience in design & development, production, quality assurance, regulatory affairs, or quality management of medical devices (related to IVD Expert)
  • Auditor training in ISO 13485 or ISO 9001 is a plus
  • Fluent in Spanish and English; Portuguese is a plus
  • Local and international business trips are required

What We Offer

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


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