Regulatory Affairs Project Manager EMEA

Regulatory Affairs Project Manager EMEA

Stryker

Multiple Locations

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.