Expert Medical Device Evaluator

2 days ago

Vijayawada, Andhra Pradesh, India beBeeMedicalDeviceAssessment Full time ₹ 20,00,000 - ₹ 25,00,000
Medical Device Assessment Expert

As a Medical Device Assessment Expert, you will be responsible for evaluating medical devices to ensure compliance with industry regulations.

The ideal candidate will have:

  • At least 10 years of professional experience in the healthcare products or related activities field.
  • 5+ years of relevant professional experience in quality management.

The minimum requirements include:

  • Good knowledge of ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, and their application.
  • Experience with Risk Management EN ISO 14971.
  • Solid knowledge of non-active devices and sterilization processes.
  • Ability to work actively with a team of assessors/auditors.

This is an exciting opportunity to develop your expertise in medical device assessment and contribute to the development of safe and effective medical devices that make a positive impact on people's lives.

Key Responsibilities:

  1. Conduct assessments and audits of medical devices to ensure compliance with industry regulations.
  2. Develop and maintain knowledge of regulatory requirements and industry standards.
  3. Collaborate with cross-functional teams to ensure effective implementation of regulatory requirements.
  4. Identify and mitigate risks associated with medical devices.

Requirements:

  • Relevant degree in engineering, medicine, or a related field.
  • Strong analytical and problem-solving skills.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and as part of a team.

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