As a Regulatory Analyst with over 3 years of experience in regulatory compliance, I specialize in ensuring medical devices and in vitro diagnostic devices (IVDs) meet global standards and regulations. My expertise lies in regulatory strategy, standard assessments, and compliance documentation, enabling businesses to confidently navigate complex regulatory landscapes. Key Highlights: - Proficient in identifying country-specific applicable standards for POC IVD and medical devices. - Performed GAP assessments for labeling, packaging, usability, and risk management standards. - Spearheaded compli