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
Oversee clinical studies, investigations and evaluations, ensuring compliance with EU MDR, FDA and other regulatory requirements
Manage collaborations with CROs and external clinical suppliers
Work cross-functionally with R&D, Marketing, Sales, Product Management and Quality Management
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
Experience in 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 cross-functional collaborations
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
Additional Information
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.