Leading Medical Devices Specialist

1 day ago


Rajkot, Gujarat, India beBeeMedicalDevice Full time US$ 1,60,000 - US$ 2,00,000

Our company seeks a senior device engineer to contribute to medical devices-assessment. With expertise in quality management and regulatory affairs, this role involves auditing and assessing medical devices to ensure they meet stringent safety and effectiveness standards.

Essential Qualifications:
  • At least 10 years of experience in the medical devices sector, focusing on quality management and regulatory affairs.
  • A minimum of 5 years of quality management experience, with a solid understanding of ISO 13485, MDD 93/42/EEC, and Indian Medical Device Regulations.
  • Knowledge of risk management (EN ISO 14971) and sterilization processes.
Desirable Skills:
  • Understanding of MDR 2017/745 and MDSAP.
  • Competence in non-active devices and sterilization processes.


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