Senior Regulatory Affairs Engineer (TCI)

You will ensure our cutting-edge medical devices meet global standards and regulations as well as align with regulatory strategies from research and development to market launch and post-market. Advise on regulatory strategy throughout the product lifecycle, influencing design, risk management, supplier selection, and device labeling. Develop and maintain regulatory documentation, including Design History File (DHF), Technical Documentation, Device Master Record (DMR) and Device History Records (DHR). Prepare, review, and submit documentation for EU MDR, FDA, and other international markets. Participate in post-market surveillance, CAPA, and complaint management activities. Coordinate communications with regulatory bodies and drive certification projects and vigilance activities, ensuring timely reporting and compliance.