Senior Regulatory Expert
4 days ago
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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