Senior Medical Device Specialist

9 hours ago


Bengaluru, Karnataka, India beBeeRisk Full time ₹ 15,00,000 - ₹ 20,00,000
Device Engineering Expertise

We are seeking an experienced Device Engineer with a strong background in medical devices and quality management.

Key Responsibilities
  • Conduct thorough assessments and audits of medical devices to ensure compliance with regulatory requirements such as ISO 13485, MDD 93/42/EEC, and Indian Medical Device Regulations.
  • Develop and implement effective risk management strategies using EN ISO 14971.
  • Collaborate with a team of professionals to identify and mitigate risks associated with non-active devices and sterilization processes.
Essential Qualifications
  • Strong knowledge of ISO 13485, MDD 93/42/EEC, and Indian Medical Device Regulations.
  • Experience with Risk Management EN ISO 14971.
  • Solid understanding of non-active devices and sterilization processes.


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