CODES & STANDARDS ENGINEER

Vrinda International; Bengaluru; On-site; INR 1,170,000 - 1,430,000; Full time

Job summary

Vrinda International seeks an experienced Codes & Standards Engineer to ensure medical device compliance, safety testing, and regulatory filings. You will work on IEC 60601-1, CE marking, EU MDR, and maintain Technical Files and GSPR documentation.

Collaboration with cross-functional teams and external labs will be essential in this role. The position requires 7+ years in medical device regulatory compliance, with work from office in Bengaluru.

Qualifications

• 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.
• Strong understanding of EU MDR requirements.
• Experience with CE Marking.
• Technical File preparation and maintenance.
• GSPR documentation and compliance.
• Product certification and regulatory audit support.
• Safety testing and compliance activities.

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.

Skills

IEC 60601-1

IEC 60601 collateral standards

Notified Bodies liaison

EU MDR

CE Marking

Technical File preparation

GSPR documentation

Regulatory audits

Safety testing

Job description

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Job Description

HIRING | CODES & STANDARDS ENGINEER ?

Experience: 7+ Years

Budget: Up to ₹13 LPA

work Mode: Work From Office – 5 Days a Week

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

• 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


• Strong understanding of EU MDR requirements


• Experience with CE Marking


• Technical File preparation and maintenance


• GSPR documentation and compliance


• Product certification and regulatory audit support


• Safety testing and compliance activities