• Lead the site-move change activities in Latam countries: make presentations, organize database, schedule meetings, and communicate effectively and strategically with SMEs, PM, directors, and international RA.• Successfully put the simple and federal apostille, notary, letter of authorization, Change description letter, and MDSAP orders.• Successfully drafted Manufacturer Change Description Letter, Certificate of Analysis, Declaration of Conformance, Letter of Authorization, and Certificate of Authorization• Successfully analyzed and completed the RAC (Change orders) according to the US and global impact.• Successfully gathered Label and IFU sampling plans for all registered countries globally and negotiated with the international RA to send fewer representative labels and IFU, which is time- and budget-efficient.

• Ensuring the regulatory impact has been thoroughly assessed before changing a product line and creating and writing submissions to the US FDA, Health Canada, BSI - our Notified Body for the EU, and the Therapeutic Goods Administration in Australia. • Maintaining the regulatory attributes for Class I sterile cables utilized on the Class II and Class III devices.• Arranged meetings with the Project managers and Senior RA managers about the supplier change notifications and delivered compelling solutions that helped finish the task within hours instead of days and weeks.• Expertly use the International Regulatory Matrix to inform the project managers about the upcoming global impacts of the change order.• Successfully updated all EP business unit BSI audit forms according to their requirements.• Successfully authored and supported LTF, 30-day submission, and traditional 510 (k).• Accurately utilize the 510 (k) flowcharts and Article 120 MDR for Regulatory Change Assessment.

• Successfully drafted the pre-market submission and strategies, change description, compelling emails, precise verbiage for regulatory attributes and rationales, and technical files.• Authored four Class II devices tech files and submitted them to TUV.• Authored Eu DoC, GSPR, and Eu Classification forms.• Successfully identified the errors and led the Gap Assessment with the cross-functional team.• Restricting and enabling the products, reviewing and approving IFU and labels in SAP and Windchill.• Supported CAPA and reviewed MVP and MVPR in detail.• Develop a strategy for Product Registration based on their limitations, certificate no., stock list, and duration.

• Authored and submitted Traditional 510 (k) submission: 510 (k) Summary, test summary reports, biocompatibility reports, substantial equivalence discussion, performance testing, abstract, general description, and indication for a new device.• Modified EU MDR tech files according to the new requirements.• Expertly communicated in the TUV and MDSAP audit regarding the change orders.• Successfully submit and received the approval for China, Vietnam, Myanmar, and Malaysia registration and imports.• Edited and Authored internal Cook Medical QMS document that compliance with EU MDR document for the Regulatory Affairs Department.• Successfully performed the import licenses for Vietnam, China, Myanmar, and Malaysia. • Introduced the idea of the acronym list and synonym list and successfully authored the lists for the Regulatory Affairs Department.

• Working in the Instrument division and joined Neurosurgical (NSE) group.• Successfully author EU MDR tech files for Class II and III product according to the new requirements and regulatory standards.• Supporting 510(k) submissions for Class II products.• Performed several Change Management Assessment, Change Notification Form For International Divisions, and 510 (k) flow chart change order assessments within the One PLM system on local product registrations. • Successfully performed and verified Product and Part Registrations for the US and Europe on Quick Base.• Attended the BSI training and successfully understand the classification rules and justification for Class II products• Successfully reviewed the Post Marketting Survelliance reports for class II products.• Successfully performed Product Registrations in US and Europe, Enterprise Change Request, and Change Notifications in one PLM and Quick Base.• Communicated effectively with the cross-functional teams and International Regulatory Affairs.• Successfully trained two associates for the RA role.

• Assisted with assembly, distribution, storage, tracking, and retrieval of information pertinent to the regulatory process including the regulatory submissions process. Reviewed and contributed to 510(k) submissions.• Successfully understand and completed the Impact Assessments and Gap Assessments.• Authored and edited 510(k) Claims, Overall Risk Beneficial Residual Analysis, CE submissions, PMA, Technical Document Reviews, and regulatory Justifications reports to support submission filing decisions. • Attended all of the assigned Design Review meetings for the remediation Polaris Project and gained basic understanding regarding the Design Inputs for the medical devices.• Successfully gained knowledge regarding the regulatory standards: ISO 21534, ISO 21536, and ISO 14630.• Enhancing and revamping changes on about 3000 SKUs (implants and instruments) labels on the Access Database and Ms. Excel according to the FDA requirements.• Identified and followed regulatory requirements such as restrictions, CE mark, Special Operating Design Input, Special Warn Design Inputs, Production ID, GS2 Barcodes, Sterile or Non Sterile, MR and IFU for labels.• Communicated effectively (and setup meetings) with Sr. Regulatory Affair Specialists, Quality and Development Engineers and reported to the upper management for progress and kept up with priority deadlines of the project.• Expertly aided in updating package inserts, ‘instruction for use’ and surgical technique as per FDA regulatory requirements.• Assisted the development leads in finding the CE (TT or DD),Clearance letters, and PMSR.• Reported missing/irrelevant markings, etchings and engravings ofimplants and instruments on prints.