Company Description
Founded in Munich, Germany in 1989, Brainlab develops, manufactures and markets software-driven medical technology, enabling access to improved, more efficient, less-invasive patient treatments. Our key to success is our creative, talented and hard-working team, which consists of around 2400 dedicated and inspiring individuals in 25 locations worldwide. To succeed in reaching our targets, we are seeking committed colleagues who can stand behind our core values curious, authentic and useful.

Job Description

• 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

QUALIFICATIONS

• Medical degree, ideally with specialization or strong background in Neurosurgery, Neurology or a related field
• 8+ years of experience in Clinical Affairs or Clinical Research 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
• Strong leadership experience in with cross-functional collaboration
• Ability to translate clinical research into scientific marketing content
• Experience managing clinical networks in Neurosurgery is highly desirable
• 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

Please refer the Job description for details