Product Information / Labeling Subject Matter Expert (SME) - Medical Devices
BengaluruFull-time10–18 yrsPosted 2 weeks ago
Leadership pharma role at NTT DATA Services in Bengaluru. Needs 10+ years and a B.Tech or B.E..
About the role
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.
What you'll do
- 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
- 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
What you need
- Regulatory affairs
- ISO 9001
- Documentation
- Root cause analysis
Good to have
- InDesign
- Illustrator