Senior Manager - Clinical Affairs

• Lead and manage the Clinical Affairs team, covering clinical evaluation/validation, clinical research and scientific marketing
• Oversee clinical studies, investigations and evaluations, ensuring compliance with EU MDR, FDA and other regulatory requirements
• Work cross-functionally with R&D, Marketing, Sales, Product Management and Quality Management
• Manage collaborations with CROs and external clinical suppliers
• Act as Process Owner for clinical evaluation and validation, training authors and evaluators to ensure regulatory compliance
• Serve as Clinical Evaluator for Class I to Class III medical devices
• Bridge the gap between clinical research and scientific marketing to generate impactful content
• Ensure GDPR compliance in clinical collaborations
• Initiate and manage clinical studies and investigations to support product innovation and regulatory approvals
• Build and maintain a strong clinical network in Neurosurgery
• Represent the company in communications with regulatory bodies for clinical trial approvals and regulatory submissions

• Technical university degree
• Strong leadership experience with cross-functional collaboration
• Several years of experience in Clinical Affairs, Clinical Research and/or R&D within the medical device industry
• 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 project management, stakeholder management and communication skills
• Strong understanding of GDPR and clinical data protection regulations
• Very good English skills, German is a plus

• A mutually-supportive, international team
• Meaningful work with a lasting impact on medical technology
• 30 vacation days, plus December 24th and December 31st
• Flexible working hours as well as 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

Ready to apply? We look forward to receiving your online application including your first available start date and desired salary. 

Contact person: Géraldine Ferrer