Labeling SME
VENKANNABABU VADDI
Natus Sensory
Bengaluru,KA
Overview
I have over 11 plus years of progressive experience in the Medical device, life sciences and healthcare sector-related design and CO, including artwork, labeling, packaging, and web/graphic design and proofreading. In-depth knowledge of the Life science, medical domain and healthcare industry enables to create accurate, compliant, and impactful designs change orders that meet industry regulations and enhance user experiences. I have a proven track record in delivering high-quality solutions that adhere to regulatory standards, ensuring that every project contributes to patient safety and product efficacy.
11+
Years of experience
Work History
08.2025 - Current1 Year 2 Months
Labeling SME
Natus Sensory | Bangalore
- 1. Stay up-to-date and follow all applicable Quality-Management-System (QMS) procedures related to this job, which can affect the quality of products or services provided to our customers.
- 2. Partner with internal departments to gather input for artworks, labeling and IFU while ensuring outputs align with QMS policies and procedures.
- 3. Support the creation of artwork, labeling and IFU source files for signature review and approval.
- 4. Participate in product development teams like labeling and IFU SME while obtaining alignment on timelines.
- 5. Proactively work with internal functional groups (Regulatory, Packaging, purchasing, manufacturing, quality, marketing, clinical, etc.) as well as external groups (ex. suppliers) as required regarding quality issues, file formats, design discussions, or other relevant issues to develop medical device labeling and IFUs that comply with applicable regulations based on labeling requirements, specifications, and prototypes.
- 6. Apply appropriate regulations that affect medical device artworks, labeling and IFUs.
- 7. Lead/coordinate efforts to continuously improve labeling and IFU procedures.
12.2021 - 08.20253 Years 8 Months
Senior Technical Lead
HCL Tech | Bangalore
- Customer Abbott laboratories
- To create/ update artwork, carton, labels, IFUs, Implants, eIFU & ePG for design as per redlining documents through artwork, labeling software tools
- Working closely with the project lead and Brand Manager's for new product development and existing products
- Created redline for initial Artwork, labels, and IFUs with support of supporting documents like SDS, Shelf-life, Bill of material, Temperature, Rx Symbol data, Gap Assessment verification and identification of document number, catalog number & symbols
- Label Redlining – English Version (IFU, Unit Label, and Shipping Label)
- Label Artwork review of English and Non-English versions (IFU, Unit Label, and Shipping Label)
- Good experience in Remediation, Proofing of artwork, labels, eIFU, IFUs & Manuals
- Updating Verification and Validation reports as per the WI or Procedure.
- Co-ordinated with external vendors for the other language translations
- Experience in Artwork, Labeling and PLM Software using TVT, Global Vision, Easy Label, Viewpoint, Xiam, ADAPTIV, Agile, Windchill, WWL, Loftware, CDR, QB & Involved in executing Product artwork, labels, eIFU, IFUs & Manuals for records in Labeling tools.
- Involved in executing CR & COs, Under Change Notices for processing Artwork, and labels but not limited to creating red lines, Change Assessments, and Change request forms.
- Conducting monthly governance calls with all internal and external stakeholders.
08.2019 - 12.20212 Years 4 Months
Senior Engineer
LARSEN AND TOUBRO TECHNOLOGY SERVICES
- Client Johnson & Johnson DePuy Synthes
- As a Senior Engineer in (Integrated Change Management) team, I was responsible for coordinating medical Device labels & ECOS Creation in PLM Software and assigning with respective stakeholders regularly to get the approvals on time as per the given timelines
- Coordinate with the labeling lead & get trained in labeling PLM software(s) and applicable standards
- Work closely with the project leader's new product development and existing teams
- MDD & MDR ISO 13485, CE Marking, Standard Labels in the creation, design, and implementation of product labeling and packaging graphics
- Develop/create graphic file work (InDesign or other systems) as needed for product labeling and packaging graphics
- Initiate documentation packages for artwork approval
- Artwork production services consisting of electronic creation of artwork files for all labeling needs, downloads and uploads of digital artwork files, file management of die line files, font management, troubleshooting synchronicity issues with partner suppliers
- Work within labeling tools/systems to modify/create label templates
- Create and manage changes within the labeling system
- Label request form creation
- Involved in executing ECOS & IFUs for processing labels but not limited to creating red lines, changing order forms, creating redlines, label request forms, etc
- Coordinate with all stakeholders for timely approval of Change Assessments and Change Orders
- Provide support to proofing of labels as and when required
- Release artwork and maintain native artwork files
- Maintain track of projects within the timelines with the current status
- Develop metrics and reports for the artwork approval timelines
- Support for end-to-end PLM's approval and process
03.2019 - 07.20194 Months
Executive - Packaging Development
LYRUS LIFE SCIENCES PVT. LTD
- As an Executive - Packaging Development, I was responsible for coordinating Health Care products designing artworks, Cartons, Blister & PIL labels for assigning to respective stakeholders regularly as per the given timelines
- Designed layout or Cutter guides and graphics and prepared for print
- Worked as a core part of QAMS-Quality Assurance Management System
- Coordinating with stakeholders in case of any comments
- Maintain track of projects within the timelines with the current status
- Provide reports for senior management with project/artwork status
- Sending FMP files (Hi-Res files) to suppliers through the Product Lifecycle Services System
- Meet with respective cross-functional teams and clients to review and revise the artwork
- Sending final approved artwork copies to the Sourcing/Planning Team
02.2018 - 02.20191 Year
Consultant - Executive RA
iMED Global SOLUTIONS
- Client Johnson & Johnson
- Manage the end-to-end process for documenting, approving, and implementing Labeling changes in the ETQ Global Change Control (GCC) system
- Ensure all required inputs (i.e., Forms) have been received and approved, if necessary, before initiation of a GCC
- Review all required inputs (i.e., Forms) to ensure a complete understanding of the change and connect with the Label Service Coordinator(s) if clarification is required
- Utilize required inputs (i.e., Forms) and Good Documentation Practices to record the specific, detailed change information in the GCC Initiation
- Identify the appropriate Subject Matter Experts (SMEs) and Plan Approvers in the GCC
- Description of Current State
- Description of Proposed State
- Rationale / Justification for Change Impact Assessment
- Implementation Strategy
- Utilize inputs (i.e., Forms) to enter the required deliverables and timing in the GCC
- Route the GCC for review/approval through the GCC system
- Follow up with SMEs and Approvers to ensure timely completion of reviews/approvals in the GCC system
- Provide GCC status updates (as appropriate) to the Label Service Coordinator(s) throughout the change control process
09.2015 - 03.20171 Year 6 Months
Senior Executive of Regulatory Operations
iMED Global SOLUTIONS
- Client Johnson & Johnson APAC
- As a Senior Executive of Regulatory Operations, I was responsible for coordinating the Artworks and proofreading artworks assigning them to the respective stakeholders regularly as per the given timelines
- Worked as a core part of QMS-Quality Management System
- Responsible mainly for review and update of the Company Core Data Sheets (CCDS) for Consumer products
- Coordinating with Regulatory, Marketing, Artwork, and Medical Affairs team members for artwork change approvals
- Assignment of Artwork and timelines of each project based on the standard timeline
- Assignment of approvers based on the approval matrix
- With in-line to regulated markets (Asia Pacific, Australia, USA, Canada, EU, and ROW)
- Coordinating with stakeholders in case of any comments conflict in the cocoon system
- Acts as the communication bridge between all stakeholders
- Sending FMP files (Hi-Res files) to the supplier through the COCOON System
- Digital proof files have been Approved/Rejected in the COCOON System
- Point of contact for any artwork and process-related questions
- Maintain track of projects within the timelines with the current status
- Develop metrics and reports for the artwork approval timelines
- Provide reports for senior management with project/artwork status
- Support for end-to-end COCOON approval and process
04.2013 - 08.20152 Years 4 Months
Artwork Coordinator
RANDSTAD INDIA PVT LTD | MUMBAI
- Client Johnson & Johnson Baby Care INDIA
- As an Artwork Coordinator, I was responsible for coordinating the Artwork Approvals with respective stakeholders and regularly getting the approvals on time as per the given timelines
- Coordinating and following up for the artwork approval with respective stakeholders within Johnson & Johnson daily by accessing the COCOON/Brando System
- Creating product code in the PLM tool
- Maintain track of projects within the timelines with the current status
- Develop metrics and reports for the artwork approval timelines
- Provide reports for senior management with project/artwork status
- Sending FMP files (Hi-Res files) to the supplier through the COCOON/Brando System
- Digital proofreading files have been Approved/Rejected in the COCOON/Brando System
- Sending final approved artwork copies (CG Specs) to the Sourcing/Planning Team
- Admin support for the end-to-end approval process
- Single point of contact across J&J India for any artwork status-related queries
Education
B Tech | CSE
St.Mary's Engineering College
St.Mary's Engineering College
Skills
Standards and regulations knowledge
- ISO 15223 - 1
- EU MDR 2017/745
- EU IVDR 2017/746
- ISO 20417
- ISO 14971
Training
- Overview of US- FDA regulation & EU MDR
- With in-line to regulated markets (USA, Canada, EU, Brexit, and ROW).
- Artwork and Label creation using Easy Label, Loftware & Adobe CC (Illustrator, InDesign & Photoshop)
- Labelling requirements of UKCA
- Loftware training
- Proofing reading software
Timeline
Labeling SME
Natus Sensory
08.2025 - CurrentRead more
Senior Technical Lead
HCL Tech
12.2021 - 08.2025Read more
Senior Engineer
LARSEN AND TOUBRO TECHNOLOGY SERVICES
08.2019 - 12.2021Read more
Executive - Packaging Development
LYRUS LIFE SCIENCES PVT. LTD
03.2019 - 07.2019Read more
Consultant - Executive RA
iMED Global SOLUTIONS
02.2018 - 02.2019Read more
Senior Executive of Regulatory Operations
iMED Global SOLUTIONS
09.2015 - 03.2017Read more
Artwork Coordinator
RANDSTAD INDIA PVT LTD
04.2013 - 08.2015Read more
St.Mary's Engineering College - B Tech, CSE
Read more