Leading the continuous development, maintenance and compliance of our QMS in accordance with ISO 13485, MDR and relevant FDA regulations., Planning, preparing and executing internal and external audits; managing CAPA, NCP and PMS processes end to end., Driving the preparation of regulatory submissions for the EU (CE marking), the US (FDA), and additional international markets., Ensuring regulatory strategy alignment across R&D, Clinical Affairs, Software/AI development and Executive Management., Supporting risk management, design control and clinical documentation activities throughout the product lifecycle., Acting as a key advisor on regulatory implications for product development and future market expansion.