Conducting regulatory GAP analyses and overseeing the interpretation and integration of applicable global regulatory requirements for medical devices into internal processes, Creating, reviewing, and maintaining high-quality technical documentation in compliance with MDR, IVDR, and other relevant standards, Developing and managing market access and registration strategies for active and non-active medical devices, including Software as a Medical Device (SaMD), with focus on regulatory compliance, Establishing, maintaining, and continuously improving Quality Management Systems (QMS) according to ISO 13485, including the preparation and maintenance of related documentation, Continuously monitoring and evaluating changes in global regulatory landscapes and implementing necessary updates to QMS and technical documentation, Leading the identification, analysis, evaluation, and documentation of product-related risks for medical devices in accordance with ISO 14971, with a strong focus on quality and compliance, Assessing the safety relevance of hazards in close collaboration with cross-functional teams and ensuring alignment with regulatory and quality requirements, Supporting and guiding project teams in the technical development and implementation of risk control measures, including effectiveness verification from a quality management perspective