25 Aug
|
Vrinda International
|
Bengaluru
25 Aug
Vrinda International
Bengaluru
HIRING | Codes & Standards Engineer
We are hiring an experienced Codes & Standards Engineer for a medical devices organization in Bangalore.
- Experience: 7+ Years
- Location: Bangalore
- Work Mode: Work From Office – 5 Days a Week
- Budget: Up to ₹13 LPA
Mandatory Skills & Experience
- Solid hands-on experience with IEC 60601-1 and collateral standards
- Medical device standards and regulatory compliance
- Experience working with Notified Bodies and safety testing labs
- Experience with UL, TÜV, ETL, DQS, LNE or similar organizations
- Strong understanding of EU MDR requirements and CE Marking
- Experience preparing and maintaining Technical Files
- Experience with STED and GSPR documentation
- Experience supporting product certification and safety testing
- Experience handling audits and compliance activities
- Strong analytical and problem-solving skills
- Excellent communication and attention to detail
Key Responsibilities
- Ensure medical device products comply with applicable codes and standards
- Support certification, safety testing and regulatory compliance activities
- Coordinate with Notified Bodies and external safety testing laboratories
- Prepare and maintain Technical Files, STED and GSPR documentation
- Support EU MDR and CE Marking requirements
- Participate in audits and resolve compliance-related observations
- Work closely with cross-functional teams to ensure product compliance
📌 Codes & Standards Engineer (Bengaluru)
🏢 Vrinda International
📍 Bengaluru