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
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
Required Skills:
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
Required Education:
Bachelors Degree in Mechanical Engineering (MBA is an added advantage).