Key Result Areas:As Specialist – Regulatory Affairs• Prepare gap analysis checklist for DHF remediation with respect to EU MDR requirement’s, applicable Product standards, and notified bodies feedback for the Instruction for Use(IFU), Patient Implant Card/Leaflet (PIC/PIL), and Labels. • Preparing the gap assessment for Product description, IFU, GSPR, LOAS, BRA/BMI, Functional Testing, Manufacturing Process Validations as QMS templates.• Remediate identified gaps to complete the Technical documentation file.• Prepare Summary of Technical Documentation (STED).• Develop Requirement List for legacy products. • Prepare DHF attribution file.• Develop Templates for multiple documents using respective standards and IMDRF guidelines.• Develop Training material to enhance Process knowledge.• Lead initiatives for work process improvements. • Project management, provide project status and monthly quality updates to stakeholders.

Growth Path:Dec’17 – Mar’21: Consultant, Technical WriterApr’21 – Jun'23: Senior Consultant, Technical Writer. Client: MedtronicKey Result Areas:• Analyse EU MDR requirement’s applicable for the Instruction for Use(IFU), Patient Implant Card/Leaflet (PIC/PIL), and Labels to prepare checklist and examples for the content. • Preparing the Label and IFU gap assessment for Medical products.• Updating the Labels and IFU documents based on MDR with following standards (ISO 15223-1, IEC 60601-1) and common specification.• Preparing process documents for Labels and IFU’s as per standards (ISO 13485). • Initiating process for ‘Special statements’ development activity, in line with EUMDR IFU’s requirement along with Cross functional team.• Conduct various IFU and Labels Cross functional review and implement changes as suggested.• Review and acknowledge IFU/Label requirements from Product Definition and Requirements (PDR) as a Technical communicator as per standards (EUMDR requirements, ISO 15223-1, IEC 60601-1).• Initiate Translation request aligned with PDR Languages requirement.• Performing translation review and preparing final PDF files for routing through Change Order to release.• Build Change order in MAP Agile for IFU/Labels/Process Documents release.• Approve Change Order as Originator/Owner and Technical communication Approver.• Upload released IFU’s on eManual site.• Update IFU templates to meet packaging requirement or to meet shipping strategy for the Device. • Develop Training material to enhance Process knowledge for Technical writers.• Lead initiatives for work process improvements. • Project management by using Scrum methodology, provide project status and monthly quality updates to stakeholders.

Key Result Areas:• Preparing the Label and IFU gap assessment for Medical products.• Updating the Labels and IFU documents based on MDR with following standards (ISO 15223-1, IEC 60601-1) and common specification.• Conduct various IFU and Labels Cross functional review and implement changes as suggested.• Initiate Translation request aligned with PDR Languages requirement.• Performing translation review and preparing final PDF files for routing through Change Order to release.• Build Change order in MAP Agile for IFU/Labels release.• Approve Change Order as Originator/Owner and Technical communication Approver.• Upload released IFU’s on eManual site.• Develop Training material to enhance Process knowledge for Technical writers.

As Senior Engineer – Virtual Manufacturing Services•Performed assembly line design and execution along with operations including developing the Sequence of Events(SOE), for a factory process assigning the Time Elements and Labor Options (for Product Variants) to determine the overall Line Efficiency for New and Existing Products•Assisted as a member in EPDP (Enterprise Product Development Process) for various harvesting, seeding, cotton and sprayer equipment•Managed process planning and industrial engineering operations like setting of labor standards, line design, line balancing, VSM and OMS (Operator Method Sheets)•Supervised projects for given unit and performedinput review, estimation for resource planning, project status communication, review and delivery•Minimized performance bottlenecks for high productivity with maximization of men, material & machineAs Engineer - Technical Author, Technical Information Authoring Centre•Provided support for New Product Program by developing manuals including Operator Manuals, Technical Manuals and Parts Catalogues•Implemented design changes and web publishes to make them available in all required languages•Generated manuals by using software including GCAWW (Arbotext Editor), MPCCS, Compact, Team Center, SAP and so on•Led the maintenance of old manual by following Engineering Change Process and Web Publish•Reviewed published materials and recommended revisions or changes in scope, format, content and so on•Assessed the final copy of a publication and produced updated editions of publications