Senior Medical Device Specialist

2 days ago


Alwar, Rajasthan, India beBeeMedicalDevice Full time ₹ 20,00,000 - ₹ 25,00,000

Job Title: Senior Medical Device Specialist

Our organization is seeking a highly experienced professional to fill the role of Senior Medical Device Specialist. In this position, you will be responsible for evaluating medical devices to ensure they meet industry standards and regulatory requirements.

Responsibilities:

  • Evaluate medical devices against ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, MDR 2017/745, MDSAP, and IMDR standards.
  • Assess risk management processes using EN ISO 14971.
  • Examine non-active devices and sterilization processes.
  • Collaborate with a team to ensure accurate and efficient assessments.

Requirements:

  • Minimum 10 years of experience in the medical devices industry or related field.
  • 5+ years of experience in quality management is essential.
  • Proficiency in ISO 13485, MDD 93/42/EEC, and Indian Medical Device Regulations.
  • Experience with Risk Management EN ISO 14971.
  • Knowledge of non-active devices and sterilization processes.

About This Opportunity: We are a reputable organization committed to excellence in our industry. If you have a passion for medical devices and quality management, we encourage you to apply.



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