RA Project Manager, CEOT & EAR

This is a permanent Hybrid role based in our Carrigtohill Cork site.

The Project Manager (Central Economic Operator Team) is responsible for the leadership and directing of complex projects within CEOT & EAR scope with the responsibility for all aspects of the project from initiation to completion. The role is also responsible with leading the verifying activities for compliance to the European Medical Device Regulations (MDR) for Stryker products, developing and applying intermediate knowledge and understanding of RA frameworks, ensuring fulfilment of regulatory obligations and timely market access in EU countries.
What you will do:

• Reviews technical documentation including labelling and instructions for use against EU MDR requirements and works with international manufacturing sites to resolve issues.
• Posts finalised technical documentation and review checklists to a central repository.
• Reports compliance metrics to the Sr Regulatory Affairs Manager, CEOT and works with the EMEA RAQA team to plan and deliver documentation reviews to specified timeframes.
• Escalates EU MDR regulatory compliance gaps and potential patient safety issues to the Sr Regulatory Affairs Manager, CEOT and international manufacturing sites in a timely manner.
• Supports the maintenance of EAR QMS.
• Provides support to the EMEA product registration team where required.
• Develops close collaboration with local RAQA teams across EMEA and international manufacturing sites to ensure timely documentation reviews and product release in EU countries.
• Performs based on established targets, KPIs and objectives for CEOT.
• Executes OneClick maintenance.
• Defines and communicates project scope, goals and deliverables for CEOT & EAR and Central RA projects.
• Assembles a project team, assigning individual responsibilities, identifying appropriate resources needed and developing schedules to ensure timely completion of the project.
• Records detailed customer requirements, constraints, and assumptions with stakeholders in order to establish the project deliverables.
• Responsible for project budget estimation, monitoring, and attainment throughout the project lifecycle.
• Ensures a common understanding by setting expectations in accordance with the project plan in order to align the stakeholders and team members
• Leads the identification, assessment, monitoring, and closure of project risks throughout the project lifecycle.
• Manages changes to the project scope, project schedule, and project costs using appropriate verification techniques in order to keep the project plan accurate, updated, and reflective of authorized changes to facilitate customer acceptance.
• Measures project performance using appropriate tools and techniques in order to monitor the progress of the project, identify and quantify any variances, perform any required corrective actions, and communicate to all stakeholders.

What you will need:
• BS or equivalent (Level 8 Degree) and 4+ years of work experience

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