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Auditor and Product Specialist for Medical Devices
hace 2 meses
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
