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Auditor & Product Expert For IVD Expert Devices
hace 2 meses
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
