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 solid 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

✅ Strong 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