Senior Medical Device Specialist

2 weeks ago

Ellore, Andhra Pradesh, India beBeeSpecialist Full time ₹ 15,00,000 - ₹ 25,00,000

Job Title: Senior Medical Device Specialist

About This Opportunity

We are seeking a highly experienced Senior Medical Device Specialist to lead our medical device operations. This is an excellent opportunity for a skilled professional with a strong background in quality management and regulatory affairs.

Main Responsibilities:
  • Evaluate and audit medical devices to ensure compliance with relevant regulations such as ISO 13485, MDD 93/42/EEC, and Indian Medical Device Regulations.
  • Develop and implement risk management strategies using EN ISO 14971.
  • Collaborate closely with assessors and auditors to ensure effective quality management practices.
Essential Requirements:
  • 10 years of experience in the medical devices industry, including research and development, manufacturing, quality management, or regulatory affairs.
  • 5+ years of experience in quality management is essential.
  • Detailed knowledge of non-active devices and sterilization processes.

This challenging role demands a high level of technical expertise and exceptional communication skills. If you are a motivated and detail-oriented professional with a passion for quality management, we encourage your application.

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