Job Summary

We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to support regulatory compliance activities for In Vitro Diagnostic (IVD) products. The role is responsible for managing and verifying Product Information Management (PIM) data, supporting regulatory submissions, and ensuring the accuracy and consistency of product information across internal systems and regulatory documentation.

The successful candidate will collaborate with cross-functional teams including Regulatory Affairs, Labeling, Quality, Supply Chain, and Marketing to maintain high-quality product data and support global regulatory requirements

Key Responsibilities

Review, verify, and maintain IVD product data within PIM systems to ensure accuracy and compliance.Generate and analyze data reports, identify discrepancies, and coordinate corrective actions.Support regulatory submissions, product registrations, labeling updates, and change controls

Skill Requirements

Must Have Skill

IVDR

Positive to Have Skill

Other Requirements

📌 Senior Reporting & Data Analyst (India)
🏢 HCLTech
📍 India