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

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

Req ID: 391651 

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, apply now.

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

Product Information & Labeling Strategy

• 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.

Risk Management & Quality

• 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.

Key Competencies

• Medical Device Labeling & Product Information

• FDA & EU MDR Regulatory Compliance

• IFU / User Manual / Packaging Labeling

• UDI, GUDID & EUDAMED

• ISO 15223-1 / ISO 20417 / ISO 14971

• Enterprise Labeling Management Systems

• PLM & Document Management

• Labeling Change Control

• Translation & Localization

• Risk Management & CAPA

• Quality Management Systems

• Cross-Functional Stakeholder Management

• Healthcare / Life Sciences Domain Expertise

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 recruiters will never ask for payment or banking information and will only use @nttdata.com, @nttdatafed.com and @talent.nttdataservices.com email addresses. If you are requested to provide payment or disclose banking information, please submit a contact us form, https://us.nttdata.com/en/contact-us.

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Experience Level

Senior Level