Quality and Compliance Manager
2 days ago
Sysmex Saudi Arabia is a dynamic and growing organization that provides medical diagnostic products and solutions in the Kingdom of Saudi Arabia.
We are seeking a highly experienced Quality and Compliance Manager to join our team.
The successful candidate will be responsible for supporting business operations for product registrations within the defined territory and providing visibility and reporting of ongoing product registrations and its status to other stakeholders with the use of the product registration trackers where required.
In addition, the ideal candidate will communicate expected product design changes received from Legal manufacturers to distributors and authorities, collecting such information from distributors and authorities on their impact, and informing the Legal manufacturer and distributor on actions resulting from these changes.
This role requires strong leadership and management skills to lead cross-functional teams and external stakeholders.
Key qualifications include:
- A bachelor's degree in a related field such as life sciences, biomedical engineering, or medical technology.
- In-depth understanding of KSA regulations and guidelines relevant to IVDs (In Vitro Diagnostic Medical Devices Regulation).
- Experience of ISO 13485 is preferable to ensure compliance with the standards as well as certificate maintenance.
- Minimum 3 years work experience in regulatory affairs & quality assurance, preferably in MD/IVD Industry.
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