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EY- GDS Consulting – Enterprise Risk - ER – Regulatory Compliance –Senior – SaMD SME - Quality Consultant

As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives.

The opportunity

We are seeking a highly experienced and detail oriented SaMD GxP Quality Consultant with robust expertise in Software as a Medical Device (SaMD)



quality governance, validation, and regulatory compliance within GxP regulated and quality critical environments. The ideal candidate will ensure the safety, reliability, integrity, and regulatory readiness of SaMD solutions while partnering with cross functional teams to establish, implement, and sustain inspection ready, compliant digital health systems.

This role is responsible for leading SaMD quality and validation activities across the full product lifecycle, including requirements definition, risk management, design controls, validation planning, deployment readiness, and post market change management, in alignment with GxP principles, risk based validation, and data integrity expectations. In addition, the consultant will own and manage SaMD lifecycle documentation and templates, including SOPs, work instructions, validation templates, and standardized quality artifacts, ensuring consistency

📌 RC-REGULATORY COMPLIANCE-CSV-Quality Lead (Delhi)
🏢 EY Studio+ Nederland
📍 Delhi