مدیر رگولاتوری

مدیریت تجهیزات پزشکی ایران تهران

منتشر شده 2 ماه پیش

Job Description

  • Submitting the necessary documents to the General Department of Medical Equipment to create the company's birth certificate.
  • Reviewing, updating, and using quality management systems.
  • Reviewing, completing, confirming, and submitting all quantitative and qualitative documents and approvals related to imported medical equipment.
  • Communicating with foreign suppliers to provide technical and quality documents.
  • Following up correspondence and announcements of foreign manufacturers and announcing special cases to the General Department of Medical Equipment.
  • Supervising the implementation of laws and regulations to carry out the distribution process according to the regulations announced by the Ministry of Health.
  • Confirming the implementation of the programs of the quality control unit.

Requirements

  • Complete mastery of the affairs and laws of the Food and Drug Organization and the Medical Equipment Administration.
  • Complete mastery of the cargo correspondence system and the TTAC and labeling system.
  • Bachelor's or Master's degree in Medical Engineering with relevant work experience.
  • Experience in the process of product registry with the Ministry of Health through imed.ir.
  • Familiarity and complete mastery of ISO technical files.
  • Familiarity with the range of company products.
  • Familiarity with the rules of importing consumer necessities.
  • Mastery of the TTAC system.
  • Familiarity with SOP writing.
  • Familiarity with pricing.
  • Familiar with the business process.
  • At least 10 years of related work experience.
  • Highly skilled in working with MS Office software and the Internet.
  • Highly fluent in the English Language, especially in formal correspondence and negotiation.

Employment Type

  • Full Time

Seniority

Details

Employment type

  • Full Time

Seniority

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