Define and lead the global Clinical Affairs strategy for Brainlab’s global surgery portfolio, ensuring alignment with product, regulatory and commercial objectives / teams
Lead and develop an international Clinical Affairs team responsible for clinical evaluation, clinical research and scientific marketing communication
Ensure clinical compliance with EU MDR, FDA and other regulatory requirements
Build and maintain a strong clinical network of investigators, key opinion leaders and research partners
Act as Process Owner for clinical evaluation and validation, training authors and evaluators to ensure regulatory compliance
Partner closely with R&D, Product Management, Marketing, Sales and Quality Management on the strategy and to translate clinical insights into product innovation and market differentiation
Bridge clinical research and scientific marketing by translating evidence into credible, high-impact scientific and educational content
Ensure GDPR compliance in clinical collaborations
Define and manage clinical studies and investigations to support product innovation and regulatory approvals
Represent the company in communications with regulatory authorities related to clinical strategy, investigations and submissions