Advanced Medical Device Professional

20 hours ago

India beBeeDevice Full time ₹ 10,00,000 - ₹ 15,40,000
Senior Device Engineer Job Description

As a seasoned medical device specialist, you will be responsible for conducting thorough assessments and audits of medical devices to ensure compliance with regulatory standards.


  • Key Responsibilities:
    • Assessment and Audit: Conduct on-site assessments of manufacturing facilities to verify adherence to regulatory standards, including ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, and MDR 2017/745.
    • Documentation Review: Review medical device documentation to identify potential risks and non-compliance issues.
    • Quality Management: Collaborate with cross-functional teams to develop and implement quality management systems.

Requirements:


  • Experience:
    • Minimum 10 years of professional experience in the healthcare products or related activities field.
    • 5+ years of relevant professional experience in quality management is essential.

  • Knowledge and Skills:
    • Good knowledge of ISO 13485, MDD 93/42/EEC, and Indian Medical Device Regulations.
    • Experience with Risk Management EN ISO 14971.
    • Solid knowledge of non-active devices and sterilization processes.

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