Senior Medical Device Compliance Specialist

1 week ago


Malappuram, Kerala, India beBeeMedicalDevice Full time ₹ 80,00,000 - ₹ 1,70,00,000

Our organization is seeking a highly skilled and experienced Senior Device Engineer to join our team. This role will involve assessing and auditing medical devices to ensure they meet regulatory requirements.

The ideal candidate will have extensive experience in quality management, risk management, and knowledge of ISO 13485 and MDR 2017/745 regulations.

Key Responsibilities:
  • Conduct thorough assessments and audits of medical devices to guarantee compliance with regulatory standards.
  • Utilize EN ISO 14971 methodology to conduct comprehensive risk assessments.
  • Collaborate closely with a team of assessors/auditors to achieve project objectives.
Requirements:
  • Minimum 10 years of professional experience in relevant field, including quality management and regulatory affairs.
  • Strong understanding of non-active devices and sterilization processes.


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