Product Information / Labeling Subject Matter Expert (SME) - Medical Devices

NTT DATA, Inc.; Bengaluru; On-site; INR 3,000,000 - 6,000,000; Full time

Job summary

NTT DATA Services in Bengaluru seeks a seasoned Product Information / Labeling SME to lead global labeling, IFU development, and regulatory documentation for medical devices.

You will interface with Regulatory Affairs, Quality, R&D, Manufacturing and IT to ensure compliant, traceable labeling across markets, manage translations, and drive ELMS and PLM enabled processes.

Qualifications

• 10+ years of experience in Healthcare, Life Sciences, and Medical Devices.
• Experience in labeling, IFUs and regulatory documentation.
• Ability to lead cross-functional teams across Regulatory, Quality and R&D.

Responsibilities

• Serve as SME for medical device product information and labeling, including IFUs and packaging.
• Define global labeling strategies for NPI and lifecycle changes.
• Conduct labeling gap analyses and regulatory impact assessments.
• Establish governance for product information and labeling across markets.
• Support regulatory audits, submissions, and remediation activities.

Skills

Product labeling

Regulatory affairs

Quality assurance

UDI knowledge

Education

Bachelor’s degree in Engineering or Life Sciences

Regulatory Affairs Certification (RAC)

Tools

Loftware

BarTender

PRISYM ID

Windchill

Arena

PLM

Adobe InDesign

Job description

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Product Information / Labeling Subject Matter Expert (SME) - Medical Devices

Date: Oct 20, 2026

Company: NTT DATA Services

NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking organization,

We are currently seeking a Product Information / Labeling Subject Matter Expert (SME) - Medical Devices to join our team in Bangalore, Karnātaka (IN-KA), India (IN).

Job Description – Product Information / Labeling Subject Matter Expert (SME) – Medical Devices

Experience: 10+ Years
Domain: Healthcare / Life Sciences / Medical Devices
Function: Product Labeling, Regulatory Affairs & Product Information Management

Position Summary

We are seeking an experienced Product Information / Labeling Subject Matter Expert (SME) with 10+ years of experience in Healthcare, Life Sciences, and Medical Devices to lead and support global product labeling, Instructions for Use (IFU), packaging, product information, and regulatory documentation initiatives.

The ideal candidate will have deep expertise in global medical device labeling regulations, UDI requirements, labeling content management, regulatory compliance, product lifecycle management, and quality systems.

This role will serve as the functional and regulatory SME for product information and labeling, partnering closely with Regulatory Affairs, Quality Assurance, R&D, Clinical Affairs, Human Factors, Product Management, Packaging Engineering, Supply Chain, Manufacturing, and IT teams to ensure product information is accurate, controlled, traceable, and compliant across global markets.

Key Responsibilities

Serve as the SME for medical device product information and labeling, including product labels, IFUs, user manuals, quick reference guides, packaging labels, implant cards, and other regulated product documentation.

Define and implement global labeling strategies supporting new product introductions (NPI), product lifecycle changes, regulatory submissions, and market expansions.

Conduct labeling gap assessments and impact analyses resulting from regulatory, product, manufacturing, or market changes.

Establish standardized processes and governance for product information and labeling across global markets.

Regulatory Compliance

Ensure labeling compliance with applicable global medical device regulations and standards, including:

FDA 21 CFR Part 801

EU Medical Device Regulation (EU MDR 2017/745)

ISO 15223-1 – Medical Device Symbols

ISO 20417 – Information Supplied by Medical Device Manufacturers

ISO 14971 – Medical Device Risk Management

Interpret regulatory requirements and translate them into actionable labeling and product-information requirements.

Support regulatory audits, inspections, submissions, and remediation activities related to labeling and product documentation.

UDI & Product Data Management

Provide expertise in Unique Device Identification (UDI) requirements and associated product master data.

Support UDI creation, maintenance, validation, and submissions to applicable regulatory databases, including GUDID and EUDAMED.

Ensure consistency between product master data, regulatory information, labeling content, packaging, and downstream systems.

Labeling Content & Lifecycle Management

Lead the creation, review, approval, revision, and retirement of controlled labeling content.

Manage labeling changes through formal document and change-control processes.

Coordinate translation and localization activities to ensure compliance with country-specific language and regulatory requirements.

Ensure appropriate version control, traceability, approval workflows, and audit trails throughout the labeling lifecycle.

Support implementation and optimization of Enterprise Labeling Management Systems (ELMS), PLM, and document/content management platforms.

Cross-Functional Collaboration

Partner with Regulatory Affairs, Quality, Clinical, Legal, R&D, Manufacturing, Supply Chain, Packaging Engineering, Human Factors, Product Management, and IT.

Translate complex technical, clinical, regulatory, and product requirements into clear and compliant customer-facing information.

Work with Human Factors and Usability Engineering teams to ensure IFUs and product documentation appropriately address usability and patient/user safety.

Coordinate with packaging and manufacturing teams to ensure approved labeling is accurately deployed into production environments.

Participate in ISO 14971 risk-management activities to ensure appropriate labeling controls are implemented for identified risks and foreseeable misuse.

Support investigations into labeling-related complaints, non-conformances, quality deviations, and field actions.

Lead or support root cause analysis (RCA), CAPA, and remediation activities related to labeling and product information.

Ensure labeling processes comply with applicable Quality Management System (QMS) requirements.

Required Qualifications

10+ years of professional experience, with significant experience in Healthcare, Life Sciences, and/or Medical Devices.

7+ years of strong hands‑on experience in medical device product labeling, product information management, regulatory affairs, quality, or related functions.

5+ years of deep knowledge of global medical device labeling regulations and standards, particularly FDA 21 CFR Part 801, EU MDR, ISO 15223-1, ISO 20417, and ISO 14971.

5+ years of strong experience with IFUs, user manuals, packaging labels, UDI, product master data, translation/localization, and labeling change control.

5+ years of experience working within regulated Quality Management Systems (QMS) and formal document/change-control environments.

Experience with Enterprise Labeling Management Systems, such as Loftware, BarTender, or PRISYM ID.

Experience with PLM/document management platforms such as Windchill, Arena, Agile PLM, or equivalent systems.

Familiarity with Adobe InDesign, Illustrator, or similar publishing/artwork tools is preferred.

Strong understanding of product lifecycle management from NPI through commercialization, maintenance, and product retirement.

Education

Bachelor’s degree in Engineering, Life Sciences, Biomedical Sciences, Healthcare, Technical Communications, Regulatory Affairs, or a related discipline.

Master’s degree and/or Regulatory Affairs Certification (RAC) is preferred.

Medical Device Labeling & Product Information

FDA & EU MDR Regulatory Compliance

IFU / User Manual / Packaging Labeling

ISO 15223-1 / ISO 20417 / ISO 14971

PLM & Document Management

Labeling Change Control

Quality Management Systems

Cross-Functional Stakeholder Management

About NTT DATA

NTT DATA is a $30 billion business and technology services leader, serving 75% of the Fortune Global 100. We are committed to accelerating client success and positively impacting society through responsible innovation. We are one of the world's leading AI and digital infrastructure providers, with unmatched capabilities in enterprise-scale AI, cloud, security, connectivity, data centers and application services. our consulting and Industry solutions help organizations and society move confidently and sustainably into the digital future. As a Global Top Employer, we have experts in more than 50 countries. We also offer clients access to a robust ecosystem of innovation centers as well as established and start‑up partners.NTT DATA is a part of NTT Group, which invests over $3 billion each year in R&D.

Whenever possible, we hire locally to NTT DATA offices or client sites. This ensures we can provide timely and effective support tailored to each client’s needs. While many positions offer remote or hybrid work options, these arrangements are subject to change based on client requirements. For employees near an NTT DATA office or client site, in‑office attendance may be required for meetings or events, depending on business needs. At NTT DATA, we are committed to staying flexible and meeting the evolving needs of both our clients and employees.

NTT DATA endeavors to make https://us.nttdata.com accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact us at https://us.nttdata.com/en/contact-us . This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. NTT DATA is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. For our EEO Policy Statement, please click here . If you'd like more information on your EEO rights under the law, please click here . For Pay Transparency information, please click here .

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