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This is a permanent Hybrid role based in our Carrigtohill Cork site.
The Project Manager (Central Economic Operator Team) is responsible for leading and directing complex projects within CEOT & EAR scope, overseeing all aspects from initiation to completion. The role also involves verifying compliance with European Medical Device Regulations (MDR) for Stryker products, developing regulatory knowledge, ensuring regulatory obligations are met, and facilitating timely market access in EU countries.
What you will do:
* Review technical documentation, including labelling and instructions for use, against EU MDR requirements and collaborate with international manufacturing sites to resolve issues.
* Post finalized technical documentation and review checklists to a central repository.
* Report compliance metrics to the Sr Regulatory Affairs Manager, CEOT, and coordinate with the EMEA RAQA team to plan and deliver documentation reviews within specified timeframes.
* Escalate EU MDR compliance gaps and patient safety issues promptly to relevant stakeholders.
* Support the maintenance of the EAR QMS.
* Assist the EMEA product registration team as needed.
* Collaborate closely with local RAQA teams across EMEA and international manufacturing sites to ensure timely documentation review and product release in EU countries.
* Operate based on established targets, KPIs, and objectives for CEOT.
* Define and communicate project scope, goals, and deliverables for CEOT, EAR, and Central RA projects.
* Assemble project teams, assign responsibilities, identify resources, and develop schedules to ensure timely project completion.
* Document customer requirements, constraints, and assumptions with stakeholders to establish project deliverables.
* Estimate, monitor, and attain project budgets throughout the project lifecycle.
* Set clear expectations to align stakeholders and team members with the project plan.
* Identify, assess, monitor, and close project risks throughout the project lifecycle.
* Manage changes to project scope, schedule, and costs to maintain accuracy and reflect authorized changes, ensuring customer acceptance.
* Monitor project performance using appropriate tools, identify variances, perform corrective actions, and communicate progress to stakeholders.
What you will need:
• BS or equivalent (Level 8 Degree) and 4+ years of work experience
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