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Inviting applications for the role of Regulatory Affairs Operations

**Work Location**: Bangalore(Work from office)

Shift- US

Have good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent, DocuBridge, etc.

Responsibilities
- Research and stay updated on regulations relevant to the industry. Provide guidance and training to staff on compliance matters.
- Monitor and report on compliance issues to management.
- Hands on experience with Medical device UDI data aggregation, country specific UDI requirements guidelines/Global UDI Regulations, labels, medical device UDI attributes and terminology, Implementation Global UDI data clean up strategy..
- Knowledge of the European Medical Device Regulation (EU MDR), EUDAMED, FDA GUDID, Understanding of Technical file content.
- Understanding on labelling artwork, labels
- Pr

📌 Specialist - Regulatory Affairs - Operations (Bengaluru)
🏢 Genpact
📍 Bengaluru