Vikram K Email & Phone Number

As a medical device senior regulatory analyst, I have expertise in following activities:1. Led the creation and release of the labels for medical devices, ensuring compliance with regulatory standards.2. Utilizing tools like LavelVision, Adobe Illustrator, BarTender to create the labels.3. Leveraged GlobalVision for efficient label comparision and defect indentification and report generation.4. Successful verification of Print-on Demand & Preprinted Labels, Tyvek lid Artworks, Carton Artworks, PICs and PRFs.5. Submission of UDI to GUDID and EUDAMED databases.6. Knowledge on the creation of IFU, aseptic presentation rationale documents, Test method validation and DesignVerification (DV) reports7. Leveraged Smartsheet for efficient execution, project timeline estimation.8. Additionally gained skills on Veeva Vault, DOORS, TCU and DCC.9. Collaborated with cross-functional teams and external stakeholders to ensure timely and successful project delivery