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• Develop and execute regulatory strategies for products and services
• Provide regulatory expertise for complex or unique issues and challenges regarding registration and compliance activities.

In the role as _Global Head of Regulatory Affairs_, you lead a global organization of approximately 80 regulatory professionals across CMC Regulatory and Regulatory Affairs and drive regulatory strategies for the established product portfolio, focusing on product integration, lifecycle management,...

• Assessing clinical evaluations as part of technical documentation assessments according to the requirements layed down in the European Medical Device Regulation (MDR)
• Preparing deficiency reports in case of non-conformities with the requirements of the MDR

Providing strategic regulatory guidance developing global regulatory strategy, planning and execution of global investigational and marketed prescription drug submissions and managing lifecycle regulatory activities in alignment with the Therapeutic Area Lead under the direction of the Senior...

• Ensuring compliance with applicable medical device software regulations and standards, including ISO 13485, ISO 14971, IEC 62304, IEC 62366 and IVDR
• Defining, maintaining, and governing software-related quality policies, procedures, SOPs, templates and lifecycle frameworks