Regulatory Affairs Project Manager EMEA (Fixed term contract)

Stryker; Pusignan; Hybride; EUR 50 000 - 70 000; Plein temps

Résumé du poste

A leading medical device company is seeking a Project Manager in Pusignan, France. The successful candidate will lead complex projects, manage resource integration, and collaborate with teams to ensure market access across Europe, the Middle East, and Africa. Requirements include a Bachelor's degree, 4+ years of relevant experience, and 1-2 years of project management experience. The position offers hybrid work flexibility and the opportunity to work on impactful projects.

Qualifications

• 4+ years of relevant experience required.
• Minimum of 1-2 years of demonstrated project management experience.

Responsabilités

• Lead execution of EMEA registration plans for assigned franchises.
• Manage project scope, deliverables, resources, and budgets.
• Collaborate with RAQA management for submission strategies.

Connaissances

Project management

Resource management

Stakeholder communication

Analytical skills

Formation

Bachelor's degree in management or related discipline

Description du poste

Overview

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