Vikram K Email and 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
Capgemini Engineering
View-
Medical Writer (Labeling & User Manuals)Capgemini Engineering Aug 2024 - PresentBengaluru, Karnataka, India1. Creating user manuals, Quick start guides, IFUs, Release notes, JIRA specifications, technical guides, and training materials for medical devices, ensuring compliance with FDA and ISO standards.2. Working closely with subject matter experts to gather information and translate technical jargon into user-friendly content.3. Leding the creation and release of the labels for medical devices, ensuring compliance with regulatory standards.4. Maintained document control and version management to ensure the accuracy of all technical documents.5. Provided training and support to fellow writers and new team members on best practices and standards.
-
Senior Regulatory & Labeling EngineerTata Elxsi Dec 2021 - Aug 2024Pune, Maharashtra, India -
Advanced Training In Biomedical ApplicationsHarvey Biomedical Nov 2021 - Dec 2021Bengaluru, Karnataka, India -
Research InternKeds Groups Aug 2020 - Sep 2020Coimbatore, Tamil Nadu, India
Vikram K Education Details
-
7.9 Cgpa -
Vailankanni Matric Hr. Sec School92% -
Vailankanni Matric Hr. Sec School98%
Frequently Asked Questions about Vikram K
What company does Vikram K work for?
Vikram K works for Capgemini Engineering
What is Vikram K's role at the current company?
Vikram K's current role is Medical Technical Writer (Labeling & User Manuals), Senior Regulatory and Labeling Engineer.
What schools did Vikram K attend?
Vikram K attended Mahendra Institutions, Vailankanni Matric Hr. Sec School, Vailankanni Matric Hr. Sec School.
Not the Vikram K you were looking for?
Free Chrome Extension
Find emails, phones & company data instantly
Aero Online
Your AI prospecting assistant
Select data to include:
0 records × $0.02 per record
Download 750 million emails and 100 million phone numbers
Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.
Start your free trial