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

​

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)
🏢 Important Company of the Sector
📍 Bengaluru