The Opportunity
QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.
Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.
What you'll be doing:
Ensure compliance of QuidelOrtho products marketed in EEMEA countries with current local regulations:
To support all regulatory, registration and external affairs activities in the region collecting and providing documents required for local approval and/or tenders, including on request activities (i.e. filing in applications, local forms).
To provide regulatory support for QuidelOrtho sales, marketing activities and the distributors requests.
To monitor implementation of new regulatory / legal requirements in the relevant countries, maintaining Regulatory submission and change tracker support and escalate to the EMEA QRC Lead.
Assistance to the EMEA QRC lead in defining regulatory strategies in support of local business operations.
Regulatory interface with distributors and local competent authority.
Assistance in EEMEA Quality Management System set-up and rolling out aligned with the Regional and Global Quality System: Product Quality Management (FSCA, Re-call, producers communications, tenders), Suppliers/Distributors Quality Management (Quality Agreement, Change Control, non conformances, internal/external audit and inspection programs), general QMS support (training plans, QSMR, Procedures). Participation in other Quality initiatives announced by Global and/or Regional QRC Management.
In country registration/declaration, tender support: Collecting Products/Production Documents, filling the local forms and drafting explanation letters in timely manner.
Tracking regulatory requests from distributors/ business (IRRT, follow-ups, escalation, archive maintenance), distributors and business team status update.
Regulatory watch: Local regulation monitoring, Regulatory change tracker support, escalation. Input to NPI and product change notification.
Assistance in EEMEA Product Quality Management (FSCA, Re-call, producers communications, tenders).
Assistance in EEMEA Suppliers/Distributors Quality Management (Quality Agreement, Change Control, non-conformance, internal/external audit and inspection programs).
What you'll need to succeed:
Overall experience 4+ years in a highly regulated environment pharma/medical.
1-2 years experience in a quality or/and regulatory role in the medical device and/or IVD industry.
University Degree (in medicine, chemistry, biology, engineering).
English (fluent must), French or Arabic/Turkish preferred.
Advanced Microsoft Office (with very good Excel) skills knowledge and capabilities.
The knowledge of national EEMEA registration procedures, IVDD/IVDR requirements, ISO9001 awareness would be a plus.
Analytical skills, versatility, agility, goal-oriented approach.
The role is based in Cairo, Egypt.
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