Descripción del empleo
With a startup spirit and 115,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it. We dream in digital, dare in reality, and reinvent the ways companies work to make an impact far bigger than just our bottom line. We’re harnessing the power of technology and humanity to create meaningful transformation that moves us forward in our pursuit of a world that works better for people. Now, we’re calling upon the thinkers and doers, those with a natural curiosity and a hunger to keep learning, keep growing., People who thrive on fearlessly experimenting, seizing opportunities, and pushing boundaries to turn our vision into reality. And as you help us create a better world, we will help you build your own intellectual firepower. Welcome to the relentless pursuit of better. We are inviting applications for the manager role of Quality Approver for MDR (Medical Device Regulation) reporting. As a Quality Approver for MDR reporting, your role involves ensuring the accuracy, completeness, and compliance of the MDR reports related to medical devices. Responsibilities Reviewing MDR Reports : Responsible for thoroughly reviewing MDR reports submitted by the relevant departments or teams. Assess the MDR reports for compliance with applicable regulatory requirements. Knowledge of relevant regulations and standards (e.g., FDA regulations, ISO 13485, GMP). Ensuring the quality of MDR reports by checking for accuracy, consistency, and clarity. Probe knowledge verifying that MDR reports contain all the necessary information and are consistent with the established reporting procedures. Working closely with cross-functional teams, such as product development, regulatory affairs, and post-market surveillance, to gather the required information and address any discrepancies or gaps in the MDR reports. Contribute to the ongoing improvement of MDR reporting processes by identifying areas for enhancement, suggesting process improvements, and participating in relevant quality improvement initiatives. Regulatory Compliance : Responsible to stay updated with the latest regulations, guidelines, and industry best practices related to MDR reporting. Training and Guidance : Provide training and guidance to other team members involved in MDR reporting, ensuring their understanding of the regulatory requirements and reporting procedures.
