Director Clinical Affairs
Clinical Affairs Director Munich, BY, Germany
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 researchand scientific marketing
- Oversee clinical studies, investigationsand evaluations, ensuring compliance with EU MDR, FDAand other regulatory requirements
- Work cross-functionally with R&D, Marketing, Sales, Product Managementand 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 regulationsand Good Clinical Practice
- Hands-on experience in clinical studies, clinical evaluationsand 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 managementand 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.