NADHIYA RAMAN
https://www.linkedin.com/in/nadhiya-raman-b41473262
Summary
Quality-driven Product Design Lead with extensive experience in product surveillance, complaint management, and regulatory compliance for medical devices. Demonstrated success in evaluating complaints, conducting risk assessments, and ensuring adherence to global standards such as 21CFR 820, 21CFR803, and ISO 13485:2016. Skilled in managing end-to-end product design activities, creating and maintaining comprehensive technical documentation, and ensuring compliance with international regulatory standards. Proven ability to drive improvements in quality and compliance through detailed analysis, gap assessments, and strategic problem-solving. Experienced in leading cross-functional teams, optimizing processes, and supporting regulatory submissions. Strong communicator with a track record of delivering high-quality results in fast-paced environments. Seeking a challenging position in a reputable organization to leverage skills and knowledge in R&D and contribute to product safety and quality.
Overview
5
5
years of professional experience
1
1
Certification
Work History
Product Design Lead
HCL Technologies
12.2023 - Current
- Worked for technical documentation of end -to -end product design & development from gathering user needs to design transfer phase as well as support Life-cycle Management (Sustaining Engineering)
- Supported technical documentation for sustainability projects and cost effective design projects includes material certification change, material change, supplier change, address change and labeling change
- Conducted cross functional technical meeting to evaluate the design trade-offs and proposed solutions
- Executed the technical documentation of Risk Management activities to ensure that design and process shortcomings are identified and appropriately addressed
- Co-ordinates with diverse technical teams like R&D, manufacturing, quality assurance and regulatory affairs to create, update and maintain the technical documentations from the design input to design transfer phase that will become part of the product design history file (DHF) for product which includes product specification, product requirement specification, artwork requirement specifications, artwork design specification, stability report, biological evaluation plan& product, and traceability matrixes and complaint Trending Analysis report
- Responsible creating engineering BOM for all packaging levels includes Transport boxes, Retail box, Consumer unit and product part (D part) in 3DX (product life cycle management software tool)
- Co-ordinates with subsystem teams, domain subject matter experts, suppliers to create, update and maintain the V&V documents like Test protocol, DVV record and reports
- Performed as key contributor to ensure that the technical documentation such as design output specifications, risk assessments, usability evaluation and V&V reports is accurate, complete, and aligned with the initial design inputs and requirements
- Performed as the technical reviewer for design control documentations.
Quality Engineer
Medical Devices, HCL Technologies
01.2023 - 11.2023
- Prepared new MDR reportability guidelines as per standards by comparing the allegations against the Medicaldevices and severity of patient impact with old version of MDR reportability guidelines, 730 report and analyzingpossible changes in reportability based on severity of adverse event
- Implemented Component codes (IMDRF – G codes) in newly created guidelines by analyzing thecomponents responsible for the allegation against the Medical Device
- Upgraded and redesigned the job aids as per client requirement
- Responsible for creation, review and/or approval of CAPA documentation in the support CAPA administration
- Worked for analyzing the root cause for discrepancies found in the newly created MDR reportability guidelines andimplemented Corrective and Prevention Action (CAPA)
- Identified areas requiring quality improvement, initiates and follows through on plans of action necessary forimplementation
- Worked closely with pro project team members to ensure CAPA and project deliverables are met
- Monitors and ensures compliance with company policies and international standards
- Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross-functional teams
- Ensured zero repeat findings from previous audits within the area of responsibility.
Product Regulatory Analyst
Medical Devices, HCL Technologies
10.2019 - 12.2022
- Spearheaded the post market surveillance by efficiently managing and evaluating the complaints from patient asafety perspective and identifying the complaints that require further evaluation according to regulations,including 21CFR part 820.198, 21CFR 803 (MDR) for all classes (I, II, III) of medical devices
- Conducted technical reviews for adverse event reporting by accurately identifying and documenting instanceswhen products are not achieving the intended performance based upon anticipated levels of frequency and/orseverity, in accordance with stablished guidelines and regulatory requirements
- Strategically applied IMDRF Codes (Annex A,B,C,D, E, F, G) to categorize adverse events based on severity,ensuring that our regulatory practices remained current and effective
- Ensured on time submissions of regulatory reports to FDA in accordance with 21CFR803 reporting requirements
- Conducted follow up with cross functional team to efficiently gather necessary information on adverse eventsacross global markets, enhancing international compliance and reporting
- Managed risk by identifying product safety issues; triaged complaints for further investigation by performing
- Product Assessment Centre Activities, including CHR (Complaint History Report) review, DHR (Device History
- Report) review, Risk review and Labeling Review with support of FMEAs, power BI and master control
- Coordinated and provide oversight in the analysis of PMS data
- Trained and mentored over 25 engineers on product knowledge, IMDRF coding, and regulatory reportingrequirements and serving as a Subject Matter Expert (SME) for Urological Critical Care Medical devices.
Education
Bachelor of Pharmacy -
Sri Ramachandra Institute of Higher Education and Research
Skills
TECHNICAL SKILLS:
- 21CFR 820 – Quality System Regulation for Medical Device
- 21CFR 803 – Medical Device Reporting
- ISO 13485:2016 – Quality Management System (QMS) for Medical Device
- IMDRF (International Medical Device Regulatory Forum) coding
- ISO 14971:2019 – Risk Management for Medical Devices
- Basics of Pharmacovigilance, Clinical trials, and ICH- Good Clinical Practice
TOOLS:
- Trackwise – Digital Quality Management Software
- Master Control – Digital Quality Management System
- Microsoft word & Excel
- 3DX- PLM tool
- Basics of PubMed search
Accomplishments
- ERS Champion Award: Awarded for exceptional contributions to quality deliverables.
- SPOT Award: Recognized for significant achievements and exceptional support.
- Client Appreciation : Acknowledged for delivering high-quality work on key deliverables
Certification
- ISO 13485:2016 – International Organization for Standardization (ISO) for Quality Management System (QMS) of Medical Devices.
- ISO 14971:2019 – International Standards of Risk Management for Medical Devices.
- Published review article “Nanoemmigel – An apercu” in International Journal of Pharmaceutical Sciences and Research as part UG project
Timeline
Product Design Lead
HCL Technologies
12.2023 - Current
Quality Engineer
Medical Devices, HCL Technologies
01.2023 - 11.2023
Product Regulatory Analyst
Medical Devices, HCL Technologies
10.2019 - 12.2022
Bachelor of Pharmacy -
Sri Ramachandra Institute of Higher Education and Research
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