Regulatory Affairs Project Manager EMEA (Fixed term contract)

Stryker; Newbury; Hybrid; GBP 50,000 - 70,000; Full time

Job summary

A leading medical devices company based in Newbury is seeking a Regulatory Affairs Project Manager to lead EMEA registration plans. Responsibilities include managing project execution, collaborating with stakeholders, and overseeing regulatory processes. The ideal candidate will have over 4 years of relevant experience and a bachelor's degree. This role offers hybrid or onsite work flexibility and is a fixed term contract for 12 months.

Qualifications

• 4 years+ relevant experience in regulatory affairs.
• 1-2 years demonstrated project management experience.

Responsibilities

• Lead execution of EMEA registration plans.
• Manage project scope, deliverables, resources, schedules, and budgets.
• Train and mentor project teams.

Skills

Leadership

Project Management

Regulatory Processes

Stakeholder Management

Education

Bachelor's degree in management or related discipline

Tools

Project Management Software

Job description

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