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Regulatory Affairs Project Manager EMEA (Fixed term contract)

Stryker
Full-time
On-site
Cork

Work Flexibility: Hybrid or Onsite 12 Months maternity leave cover. (Fixed term contract) Position Summary Under general direction, responsible for the leadership and directing of complex projects, which often require resources and functional integration. Responsibility for all aspects of the project from initiation to completion. Interfaces with all stakeholders affected by the project, including end users. Develop, implement and maintain compliant, harmonised, best practice market clearance / registration processes across Europe, Middle East and Africa. Provide maturity and significant RA experience and expertise to the EMEA RAQA team to accelerate market access. Partner with the business by driving regulatory processes and activities through strategic projects. What you will do: Lead the execution of EMEA registration plans for assigned franchises, ensuring high-quality regulatory dossiers and timely approvals/renewals. Serve as primary contact with Stryker Design Divisions for market clearance and renewal activities, supporting ongoing market access aligned with business strategy. Collaborate with RAQA management and International RA teams to develop and execute submission strategies, share best practices, and optimize product registration processes. Participate in product lifecycle management planning and maintain RA execution throughout all phases of the product lifecycle. Manage project scope, deliverables, resources, schedules, and budgets; monitor performance, risks, and changes to ensure timely, efficient project completion. Lead, train, mentor, and motivate project teams to improve performance, enhance collaboration, and ensure project efficiency. Record and communicate customer requirements, constraints, and assumptions; align stakeholders through clear expectations and project plans. Analyze and monitor franchise registration activities, using appropriate tools to track performance, implement corrective actions, and support EMEA/Country RAQA teams. What you need Required Bachelor's degree with an emphasis in management or related discipline or equivalent 4 years + relevant experience Minimum of 1- 2 years demonstrated project management experience Preferred: Project management experience in medical devices PMP certification or equivalent (i.e. PRINCE2) Prior divisional or site experience desired #IJ Travel Percentage: 10% Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: www.stryker.com Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.

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