Senior Medical Devices Compliance Specialist

4 days ago


Thoothukudi, Tamil Nadu, India beBeeQuality Full time ₹ 18,00,000 - ₹ 25,00,000
Job Overview:

We are seeking a highly experienced Senior Device Engineer to assess and audit medical devices in compliance with regulatory standards.

  • Assess and audit medical devices to ensure compliance with ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, MDR 2017/745, MDSAP, and IMDR.
  • Experience working with risk management EN ISO 14971 and solid knowledge of non-active devices and sterilization processes.
  • Work collaboratively as part of a team of assessors/auditors.
Key Responsibilities:
  • Minimum 10 years of professional experience in the relevant field of healthcare products or related activities.
  • 5+ years of relevant professional experience in quality management is essential.


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