Regulatory Affairs Professional | Quality Management Specialist | FDA & ISO 13485 ComplianceI am a dedicated and results-oriented Regulatory Affairs professional with a Pharm.D. and currently pursuing a Master’s in Regulatory Affairs at Northeastern University, Toronto. My expertise lies in navigating complex regulatory frameworks, ensuring compliance with FDA, ISO 13485, and global healthcare regulations, and driving quality management initiatives.With hands-on experience at Genpro Research, I have developed proficiency in CAPA management, internal audits, and health technology assessments (HTA). I have successfully contributed to regulatory submissions, clinical study reports, and product labeling, facilitating smooth market entry for innovative healthcare products.My skillset includes post-market surveillance activities such as adverse event reporting, complaint handling, and regulatory change assessments, ensuring continuous compliance and product safety. Leveraging real-world evidence (RWE) analysis and cross-functional collaboration, I deliver data-driven solutions that align with evolving regulatory landscapes and payer requirements.Passionate about driving healthcare innovation, I strive to combine technical expertise with strategic insights to support businesses in bringing safe, high-quality products to market. Let’s connect to explore opportunities in regulatory compliance, quality management, and advancing healthcare solutions.