Regulatory Affairs Project Manager EMEA
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
12 Months maternity leave cover.
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
- Bachelors degree with an emphasis in management or related discipline or equivalent
- Minimum of 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
Required Experience:
IC
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongsid ... View more
