Senior Engineering Professional

23 hours ago

Mangalore, Karnataka, India beBeeMedicalDeviceExpert Full time ₹ 2,00,00,000 - ₹ 2,50,00,000
Lead Medical Device Expert

We are seeking an accomplished Lead Medical Device Expert to join our team in the healthcare industry.

About the Role:
  • This position requires approximately 10 years of experience in quality management, research and development, manufacturing, or regulatory affairs related to medical devices.
  • A minimum of 5 years of professional experience in quality management is essential.
Main Responsibilities:
  1. Evaluate and audit medical devices to ensure compliance with ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, MDR 2017/745, MDSAP, and IMDR.
  2. Collaborate with a team of assessors/auditors to implement risk management processes effectively, including EN ISO 14971.
  3. Develop and maintain expertise in non-active devices and sterilization processes.

Please note that we value diversity and inclusion in our workplace, promoting a culture where everyone can contribute their best work.

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