Senior Analyst, DI&T,

Quality Engineer, Process Engineer, procurement & supply chain
Hays Recruitment are currently recruiting for an experienced Senior Analyst for DI&T to join our client, a leading Medical Device company based in Cork.

Position title: Senior Analyst, DI&T, Regional Deployment
The Deployment Senior Analyst, Digital Identification & Traceability, will be a key role in the DI&T department within the Supply Chain organisation, and report to the Regional Deployment Manager. This role will be responsible for supporting the execution of different programs within the Unique Device Identification (UDI) , with a primary alignment to our MDR Program.
The resource will serve as a point of contact and have day-to-day operational interaction with our Supply Chain partners, multiple business franchises and other functions as we
execute our UDI Registration Readiness & Post Registration activities in support of the MDR program.

The scope of the current role includes:

o Regional (EMEA) support for primarily UDI, supporting as required our wider DI&T base business activities in the area of Serialisation & GDS, and emerging product identification and tracking capabilities
o Supporting global DI&T initiatives including shared systems and overlapping synergies to drive standardisation and compliance Business Breadth – All segments (Pharma, Consumer and Med Devices), End-to-End SC
functions (Plan, Source, Make, Deliver, Quality), Commercial, IT, Data, Regulatory Affairs
and Finance. Levels of influence – Peers, Managers, Directors on a Global & Regional basis.

Key Responsibilities:
UDI EUDAMED Registration Readiness & Post Registration activities such as
o EUDAMED Playground testing for all subsequent UDI & regression testing upon the release of other modules
o Test Script documentation, execution and impact assessment on variations, data seeding
o DI&T EMEA documentation development & Global documentation as required
o Supporting Franchise Registration readiness activities including data issue resolution & if required, training delivery
o Hypercare & ownership of EMEA UDI helpdesk tickets as Franchises
transition to Base business
o Process mapping
o BUDI Generation Support to support increase in requests triggered by MDR
o Assist Franchises to stay in sync with requirements when new data
requirements and process changes arise

Partner with business leaders, Technology, Commercial, MAKE and DELIVER organisations to provide the highest level of data quality and enable efficient digital strategies for our customers
Own specific tasks as part of larger projects to ensure timely and within budget delivery while coordinating tasks across functions and geographies
Support the DI&T Product Owner teams,(UDI and GDSN), in the development of strategy, scope and plans for new market regulations, compliance requirements & data delivery requests to both create and take advantage of data enabled
opportunities
Constantly driving our regulatory UDI compliance strategy within the Supply Chain to ensure key milestones are met for regional compliance to the laws and statutes relating to Serialisation and UDI.

What you need to do now
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Summary

Job Type
Permanent
Industry
Pharmaceuticals
Location
Cork
Specialism
Process Engineer
Pay
DOE
Ref:
1086254

Talk to a consultant

Talk to Noel O' Donovan, the specialist consultant managing this position, located in Hays Recruitment, Cork
54 South Mall, Cork

Telephone: +353 21 4648197