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Define and lead the global Clinical Affairs strategy for Brainlab's global surgery portfolio, ensuring alignment with product, regulatory and commercial objectives / teams...

• Risk Identification & Assessment - Analyze risks related to product development, manufacturing, post market, useability, biocompatibility, cybersecurity, vigilance, compliance, etc..
• Implementation of Risk Controls - Develop strategies to minimize risks and improve processes.

• Drive global CMC strategies for clinical trial applications, new product licenses, and post-approval changes.
• Assess CMC, facility/equipment, and plasma-related changes and manage regulatory submissions in coordination with regional teams.