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Eps

Quality and Regulatory Specialist

İstanbul Anadolu, İstanbul Avrupa

Eps - Quality and Regulatory Specialist

Job Definition

Reports To
The QRC Specialist will report to CEE QRC Manager.

We are looking for Quality and Regulatory Specialist which is responsible to follow product registration, post market surveillance activities and support ISO 9001 Quality Management System studies in Central and Eastern Europe to our customer.

Responsibilities and Duties

Provide a bullet point list of the responsibilities and duties of this job

  • Responsible for writing and reviewing ISO 9001 QMS procedures, ensure local activities are in accordance with CEE and global Getinge procedures, support SSU about full compliance,
  • Support registering products in the countries under Turkey Sales and Service Unit (SSU), ensure local regulations are met by the SSU,
  • Support SSU about product traceability activities in UTS,Following local regulation changes and take proper actions proactively,
  • Support post market surveillance activities, including authority notifications and closure follow up,

Qualifications

  • Bachelor’s Degree, preferable from Chemistry or Biology,
  • Min. 3 years of experience in Quality departments of medical device or pharma companies, experience in regulatory departments will be an asset,
  • Has strong knowledge about ISO 9001:2015 and ISO13485:2016
  • Fluency in English is a must,
  • Ability to work well with multiple internal partners,
  • Ability to multitask efficiently,


*EPS , Türkiye İş Kurumu Özel İstihdam Bürosu izin belgesi ve Geçici İş İlişkisi Yetki sahibidir. Belge No : 10 Tarih : 23.03.2018. 4904 Sayılı Türkiye İş Kurumu Kanunu gereğince İŞ ARAYANLARDAN ÜCRET ALINMASI YASAKTIR!