Wrig Nanosystems
Website:
truehb.com
Job details:
🚀 Hiring: Regulatory Affairs Executive | Medical Devices / IVD
📍 Location: Parwanoo, Himachal Pradesh
💼 Role Type: Full-Time
🏢 Company: Wrig Nanosystems
Experience: 0-2 years
Wrig Nanosystems is looking for a Regulatory Affairs Executive to support regulatory compliance, technical documentation, and quality activities for innovative medical device and diagnostic products.
Key Responsibilities:
✅ Support regulatory activities related to MDR, CDSCO, and international compliance
✅ Prepare and maintain technical documentation, DHF, DMF, PMF, V&V reports
✅ Support compliance activities for ISO 13485 and risk management processes
✅ Assist in software-related documentation, validation, and traceability activities
✅ Coordinate with R&D, Quality, and cross-functional teams
Requirements :
✔ Background in Biomedical / Biotechnology / Medical Devices / Life Sciences / Engineering
✔ Knowledge of Medical Devices, IVD, Regulatory Affairs, or Quality Systems
✔ Understanding of ISO 13485, MDR, CDSCO, Risk Management preferred
✔ Strong documentation and analytical skills
✔ Freshers with relevant knowledge and experienced candidates can apply
Preferred Skill:
• Medical Devices / IVD
• Regulatory Affairs
• ISO 13485 / ISO 14971
• CDSCO / MDR / IVDR
• Technical Documentation
• Software Validation / IEC 62304 (preferred)
📩 Apply at: diksha.kashyap@wrig.in
Join us in building next-generation diagnostic technologies and shaping the future of healthcare.
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