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and validation protocols. Your contributions will be crucial in ensuring the successful execution of validation and verification activities required ahead of regulatory approval and product launch. Responsibilities include: Supporting with verification & validation to prepare the LEX System for clinical study and FDA approval. Implement verification and validation test plans … and protocols for the system/product, documenting all activities within the Quality Management System (eQMS). Contribute to the development of Work Instructions and Standard Operating Procedures (SOPs). Collaborate with the Engineering, Manufacturing and Biology teams working towards regulatory submission and product launch. Adhere to the … requirements of working in an ISO 13485/FDA regulated environment. Experience and skills required to be successful in this position: Practical experience in verification of In Vitro Diagnostic (IVD) devices or medical devices in an ISO13485/21CFR regulated environment. Previous experience in writing test protocols in line more »