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Design and deliver clinical performance study strategy, protocols, and reports for IVDR and CDx programs. Define and address clinical evidence requirements, providing clinical input into product risk evaluation and study design. Partner closely with
Contribute to the development of the audit strategy & program and plans related to the GVP area-PV processes, vendors, Partners and affiliates; Act as a GVP Audit Program Owner when delegated by Global Quality GCP/GVP Head; Perform and coordinate PV
Define and execute EU regulatory strategies in alignment with global development plans. Serve as primary EU regulatory contact with EMA and coordinate interactions with National Competent Authorities. Lead preparation and execution of Scientific Advice,
Lead and oversee all Regulatory Affairs activities across the European Union, ensuring regulatory compliance, lifecycle management, and strategic regulatory support for existing and new products. Drive regulatory strategy, manage the team