Codes & Standards Engineer

Salary :

₹1,300,000 monthly

Company : Vrinda International

Job Type : Full Time

Bengaluru, India

Job Description - Codes & Standards Engineer

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

Requirements

Key Skills & Requirements

â Strong hands-on experience with IEC 60601-1

â Knowledge of IEC 60601 collateral and particular standards

â Experience working with Notified Bodies and safety testing labs

â Exposure to UL, TÃV, ETL, DQS, LNE, etc.

â Strong understanding of EU MDR requirements

â Experience with CE Marking

â Technical File preparation and maintenance

â STED documentation experience

â GSPR documentation and compliance

â Product certification and regulatory audit support

â Safety testing and compliance activities

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