Medical Devices Audit and Assessment Specialist

4 days ago


Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 20,00,000 - ₹ 25,00,000

Medical Devices Audit and Assessment Professional

 

We are seeking an experienced Medical Devices Audit and Assessment Professional to join our esteemed organization. In this role, you will be responsible for assessing and auditing medical devices in the oil and gas industry.

Responsibilities:

  • Assess and audit medical devices in accordance with ISO 13485, MDD 93/42/EEC, Indian Medical Device Regulations, and MDR 2017/745.
  • Review and evaluate risk management plans and sterilization processes.
  • Collaborate with a team of professionals to ensure compliance and quality standards.

Requirements:

  • Minimum 10 years of experience in a relevant field of healthcare products or related activities.
  • 5+ years of experience in quality management is essential.
  • Solid knowledge of non-active devices and sterilization processes.

Essential Skills:

  • Good understanding of regulatory affairs.
  • Experience with Risk Management EN ISO 14971.

 

If you possess the necessary skills and qualifications, we encourage you to submit your application along with your updated CV.



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