Sustainable Infrastructure seeks a Regulatory Affairs Manager for our Bristol client to lead global SaMD regulatory submissions, strategy, and lifecycle oversight. Hybrid role with on-site two days per week, you will coordinate UK, EU MDR/CE, and US FDA processes, ensuring safety and compliance from concept through post-market activities.
You will liaise with MHRA, FDA, and Notified Bodies, driving regulatory delivery across cross-functional teams and maintaining rigorous documentation and
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Global SaMD Regulatory Lead (Hybrid, Bristol) employer: ALFA AI GmbH
ALFA AI GmbH is an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration in the heart of London. With a strong emphasis on employee growth, you will have access to cutting-edge projects in AI-driven technology, alongside flexible hybrid working arrangements that promote work-life balance. Join us to be part of a forward-thinking team where your contributions directly impact the future of global marketplace solutions.
