Currently my project focuses on international registration (EU MDR, Japan PMDA) and Design control activities and Letter to file.

Worked as an international Regulatory Affairs Specialist for various market and also provided RA support for new products.• Performed Gap assessments on new and existing standards such as ISO, ASTM, and IEC.• Approved Label change requests and Marketing documents for the responsible product (Implants, Biologics, and Software).• Registered products for the international/ Global markets for APAC (India, Vietnam, Singapore, Japan, and Australia), LATAM (Mexico, Costa Rica, and Colombia), and EMEA (the United Kingdom and Europe)• Coordinate with vendors for translation of marketing materials, labels, and IFUs.• Performed Gap assessment for EU MDR remediation project.• Prepared Technical file for Class I and Class II medical device and SAMD. • Reviewed and approved Marketing documents such as promotional materials for various devices such as Implants, Biologics, and software devices (medical devices and non-medical devices) for advertising on the different social media platforms, product websites, and email notifications.

- Participated in Regulatory and Quality Assurance Activities.- Maintained and monitored applicable regulatory License, Change request (design change, Document change request, product labels) and IFU. - Resolved customer complaints (Product and service complaints), Non- Conformance product. - Participated in Internal and external audits. - Drafted, reviewed and approved several document in Design control and risk management. - Created Technical file document for class II device.

- Reviewed and approved Design Control and Risk Management documents for class I, II and III device.-Initiated change request for Labels and IFU.- Participated in Design review activities.

Gained Hands on experience on several diagnostic devices.