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Product Specialist/Expert for Medical 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 non-active products area in your field of expertise.
- Sterilize and non-sterilize devices, including implantable devices such as orthopedic and dental implants, mesh and instruments, etc.
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 Expert).
- Four years of professional experience is a plus, which can be partially substituted by the work at TUV Rheinland.
- Auditor training is a plus ISO 13485 or ISO 9001.
- Knowledge of relevant guidelines, norms, and product specific standards.
- 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) and driver's license.
What We Offer:
- Stable job with an open-ended contract.
- Training provided by the company.
- Salary to be agreed.
- Annual working day 1760 effective hours.
