Sangita S.

Regulatory Cybersecurity, Privacy, and Compliance Specialist with 8+ years of expertise in securing medical devices and healthcare technologies. Skilled in embedding secure-by-design principles into SaMD, IoT, and AI-driven medical applications, ensuring compliance with HIPAA, GDPR, ISO 13485, IEC 62304, and FDA 510(k) regulations. Experienced in cybersecurity governance, risk management, and regulatory policy development, integrating STRIDE threat modeling, OWASP secure coding, and AWS security architectures into medical software and firmware. Adept at NIST CSF implementation, privacy impact assessments, and global data protection laws (PIPEDA, PDPA, MDSAP), ensuring seamless compliance across jurisdictions. A strategic leader in QMS optimization, risk mitigation, and regulatory audit readiness, aligning security, privacy, and compliance with business objectives in an evolving digital healthcare landscape.