Senior Regulatory Expert

4 days ago


Riyadh, Ar Riyāḑ, Saudi Arabia Sysmex Saudi Arabia Full time

Job Description

We are seeking an experienced Regulatory Affairs Specialist to join our team at Sysmex Saudi Arabia in Riyadh, Saudi Arabia. The successful candidate will have a solid understanding of ISO 13485 and experience in implementing quality management systems.

Main Responsibilities:
  • Quality Management: Assist in all tasks related to QMS implementation & ISO certification as well as system upgrade whenever required within KSA Office.
  • FSCA Monitoring: Monitor and close out field corrective actions (FSCAs) in the affected designated territory.
  • Status Updates: Provide periodic updates of FSCA status to Regulatory and Quality Director and other stakeholders in the designated territory.

Qualifications:

  • Education: A bachelor's degree in a related field such as life sciences, biomedical engineering, or medical technology.
  • Regulatory Knowledge: In-depth understanding of KSA regulations and guidelines relevant to IVDs (In Vitro Diagnostic Medical Devices Regulation).
  • Quality Knowledge: Experience of ISO 13485 is preferable to ensure compliance with the standards as well as certificate maintenance.
  • Experience: Minimum 3 years work experience in regulatory affairs & quality assurance, preferably in MD/IVD Industry.


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