EEMEA QRC Specialist - Egypt At Ortho Clinical Diagnostics Egypt - Work From Home | medicine, chemistry, biology, engineering Vacancy
We are currently looking for an EEMEA QRC Specialist to join our QRC team.
What you'll be doing :
Ensure compliance of Ortho Clinical Diagnostics 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 Ortho 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 enviroment 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