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- Tasks: Lead complex regulatory projects across EMEA, ensuring timely market access and compliance.
- Company: Join a leading medical device company with a focus on innovation and collaboration.
- Benefits: Enjoy a hybrid work model, competitive salary, and 12 months maternity leave cover.
- Why this job: Make a real impact in healthcare by driving regulatory processes and enhancing market access.
- Qualifications: Bachelor's degree and 1-2 years of project management experience, preferably in medical devices.
- Other info: Dynamic role with opportunities for mentorship and professional growth.
The predicted salary is between 36000 - 60000 £ per year.
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
Travel Percentage: 10%
Regulatory Affairs Project Manager EMEA (Fixed term contract) in Newbury employer: Stryker
Contact Detail:
Stryker Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Affairs Project Manager EMEA (Fixed term contract) in Newbury
✨Tip Number 1
Network like a pro! Reach out to your connections in the regulatory affairs field, especially those who work at companies you're interested in. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by researching the company and its projects. Understand their regulatory processes and be ready to discuss how your experience aligns with their needs. We want you to shine!
✨Tip Number 3
Showcase your project management skills during interviews. Use specific examples from your past experiences to demonstrate how you've led teams and managed complex projects. This is your time to impress!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Regulatory Affairs Project Manager EMEA (Fixed term contract) in Newbury
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experiences that match the job description. Highlight your project management experience, especially in regulatory affairs, to show us you’re the right fit for the role.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you’re passionate about regulatory affairs and how your background aligns with our needs. Don’t forget to mention any relevant certifications like PMP or PRINCE2!
Showcase Your Achievements: When detailing your experience, focus on specific achievements rather than just duties. Use metrics where possible to demonstrate how you’ve successfully led projects or improved processes in the past.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you don’t miss out on any important updates during the process!
How to prepare for a job interview at Stryker
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of regulatory affairs, especially in the EMEA region. Familiarise yourself with the latest regulations and best practices in market clearance and registration processes. This will show that you're not just a candidate, but someone who understands the landscape.
✨Project Management Prowess
Since this role involves leading complex projects, be ready to discuss your project management experience in detail. Prepare examples of how you've managed project scope, deliverables, and budgets in the past. Highlight any PMP or PRINCE2 certifications you have, as they can give you an edge.
✨Stakeholder Engagement Skills
This position requires interfacing with various stakeholders, so think about how you've successfully communicated and aligned expectations in previous roles. Be prepared to share specific instances where you’ve led teams or collaborated with different departments to achieve project goals.
✨Show Your Leadership Qualities
As a potential leader, it’s crucial to demonstrate your ability to mentor and motivate teams. Think of examples where you’ve trained or guided colleagues to improve performance. This will help interviewers see you as a proactive leader who can enhance collaboration within the team.