HIRING | CODES & STANDARDS ENGINEER ?

Location: Bangalore

Experience: 7+ Years

Budget: Up to ₹13 LPA work Mode: Work From Office – 5 Days a Week

Role: Codes & Standards Engineer

Domain: Medical Devices & Regulatory Compliance

About the Role

We are looking for an experienced Codes & Standards Engineer with robust expertise in medical device standards, safety compliance, certification, and regulatory requirements.

Key Responsibilities
Ensure compliance with applicable medical device standards and regulations
Support IEC 60601-1 safety and compliance activities
Coordinate with Notified Bodies and external safety testing laboratories
Support EU MDR and CE Marking requirements
Prepare and maintain Technical Files, STED, and GSPR documentation
Support product certification, audits, and safety testing




Analyze regulatory and standards requirements and provide compliance guidance
Collaborate with cross-functional teams to resolve compliance-related issues

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Requirements

Key Skills & Requirements

✠Robust hands-on experience with IEC 60601-1

✠Knowledge of IEC 60601 collateral and particular standards ✠Experience working with Notified Bodies and safety testing labs ✠Exposure to UL, TÜV, ETL, DQS, LNE, etc.

✠Solid understanding of EU MDR requirements ✠Experience with CE Marking ✠Technical File preparation and maintenance ✠STED documentation experience ✠GSPR documentation and compliance ✠Product certification and regulatory audit support ✠Safety testing and compliance activities

📌 Codes & Standards Engineer Bengaluru
🏢 Vrinda International
📍 Bengaluru