Senior Manager - Clinical Affairs

• 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

• Advanced scientific, medical or technical degree (PhD, MD, or equivalent preferred)
• Extensive experience in Clinical Affairs, Clinical Research within the medical device industry
• Strong background in clinical and regulatory requirements for Class I–III medical devices
• Demonstrated leadership experience, including managing international or cross-functional teams
• Several years of experience in Clinical Affairs, Clinical Research and/or R&D within the medical device industry
• Clinical and regulatory background for Class I to Class III medical devices
• In-depth knowledge of EU MDR, FDA regulations and Good Clinical Practice
• Hands-on experience in clinical studies, clinical evaluations and regulatory submissions for medical devices
• Ability to translate clinical research into scientific marketing content
• Excellent stakeholder management, communication, and project leadership skills
• Solid understanding of GDPR and clinical data protection requirements
• Very good English skills

German is a plus

• 30 vacation days, plus December 24th and December 31st
• Flexible working hours
• Hybrid work model within Germany
• Bike leasing via cooperation partner "BikeLeasing"
• Parking garage and safe underground bike storage
• Award-winning subsidized company restaurant and in-house cafes
• Variety-rich fitness program in our ultra-modern 360m2 company gym
• Regular after work, team, and company events
• Comprehensive training and continuing education opportunities