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 strong 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

✅ Solid 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.
✅ Strong 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