Join NTT DATA as a Product Information / Labeling Subject Matter Expert (SME) for Medical Devices. This role is pivotal in shaping global product labeling, ensuring compliance, and managing product information throughout its lifecycle.

You will leverage your extensive experience in the healthcare and life sciences sectors to lead critical initiatives. This includes developing strategies for product introductions, managing lifecycle changes, and ensuring adherence to stringent global medical device regulations.

Collaborate extensively with cross-functional teams, including Regulatory Affairs, Quality Assurance, R&D, and Manufacturing. Your expertise will ensure product information is accurate, controlled, traceable, and compliant across all markets.

Spearhead the development and implementation of global labeling strategies for medical devices, encompassing labels, Instructions for Use (IFU), and packaging.

Ensure strict compliance with global medical device regulations such as FDA 21 CFR Part 801, EU MDR, and relevant ISO standards.

Provide expert guidance on Unique Device Identification (UDI) requirements and manage product master data, ensuring consistency across all systems.

Lead the lifecycle management of labeling content, including creation, review, approval, and revision processes, while maintaining robust change control.

Foster strong cross-functional partnerships to translate complex requirements into clear, compliant product information and documentation. Support risk management activities and investigations into labeling-related issues.

A Bachelor's degree in a relevant field such as Engineering, Life Sciences, or Regulatory Affairs is required.

Possess 10+ years of professional experience, with a minimum of 7 years focused on medical device product labeling, regulatory affairs, or quality.

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

Significant experience with IFUs, packaging labels, UDI, product master data, and labeling change control is essential. Experience with Enterprise Labeling Management Systems and PLM/document management platforms is highly beneficial.