Ortho Clinical Diagnostics is committed to improving and saving lives with
diagnostics. To do this we hire people who share this dream and are ready for
new adventures. As a valued team member, you will carve your own career path
and be part of building this company stronger and better than ever before.
There is no limit to the experiences, opportunities and new directions you
will have access to here at Ortho Clinical Diagnostics. More importantly, you
will be driving the surge of a whole new direction in important medicine.
That’s something we can all take pride in as we take this journey together.
Ortho is known in the industry as a leader in customer service and support.
Deeply understanding and exceeding the needs of our clinical lab, hospital and
blood bank customers is what we do. It’s who we are. If you join Ortho, no
matter what your role, you will be expected to keep that Customer Excellence
focus in your work.
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
* T racking regulatory requests from distributors/ business (IRRT, follow-ups, escalation, archive maintenance), distributors and business team status update
* R egulatory watch: Local regulation monitoring, Regulatory change tracker support, escalation. Input to NPI and product change n otification
* 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 medecine, 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