Clinical Affairs Medical Expert (MD)
We are seeking a medically qualified clinical expert to provide independent medical and scientific input across Brainlab’s portfolio of image-guided surgery, surgical planning, navigation, medical imaging and related technologies. The role combines clinical evaluation and medical documentation review with practical clinical advice to R&D, Product Management and other functions. The position supports multiple business areas, including cranial, spine & trauma, ENT, CMF, general surgery and other Brainlab clinical application areas.
Key responsibilities
- Keep overview over key scientific and clinical methods and developments in clinical fields addressed by portfolio. Act as Clinical Advisor for respective fields.
- Review and provide medical input to Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), state-of-the-art (SOTA) reviews, design validation strategies and clinical evidence assessments; review and sign off on documentation within assigned authority and qualifications.
- Critically evaluate published literature, clinical data, indications, medical claims, clinical benefits and safety/performance evidence across the product lifecycle.
- Provide medical input to post-market surveillance (PMS), post-market clinical follow-up (PMCF), risk management and clinical evidence-generation strategies.
- Advise R&D, Product Management, Regulatory Affairs, Quality Management and other teams on clinical workflows, intended use, product requirements, usability and clinical risks.
- Partner with Regulatory Affairs and Quality to align clinical evaluations, benefit-risk assessments and post-market evidence with applicable EU MDR requirements and current guidance.
- Translate firsthand experience of clinical practice and medical technology use into actionable recommendations for product design and improvement.
- Support medical review of clinical study concepts, protocols and scientific collaborations; engage with external clinicians and key opinion leaders as needed.
- Contribute to clinical training, education and scientific content, ensuring clinical accuracy and relevance.
- Completed medical degree (MD or equivalent medical degree with completed clinical training and hands-on patient care experience).
- Relevant clinical practice experience in a specialty aligned with Brainlab technologies (e.g., neurosurgery, ENT, CMF, spine surgery, or other clinically active specialties involved in procedural and image-guided patient care).
- Strong understanding of clinical workflows, evidence-based medicine and critical appraisal of scientific literature.
- Ability to independently assess clinical and scientific documentation and communicate sound medical judgments.
- Effective cross-functional collaboration and clear written and spoken English.
Preferred qualifications
- Specialist training or board-certification in a relevant discipline; Experience in image-guided therapies and related clinical environments is an advantage.
- Hands-on clinical use of Brainlab products (e.g., navigation, surgical planning, and image-guided interventions) or comparable technologies.
- Experience with CT/MRI-based planning, image guidance, intraoperative imaging, surgical navigation
- Familiarity with medical device regulatory requirements, particularly EU MDR (Regulation (EU) 2017/745), clinical evaluation, and PMS/PMCF; willingness to develop further regulatory expertise.
- Practical experience preparing or reviewing EU MDR clinical evaluation documentation, including CEPs/CERs, PMS/PMCF plans and reports, and supporting notified-body or regulatory questions.
- Clinical research, publications, or experience collaborating with multidisciplinary clinical and engineering teams.
- Fluent German language skills.
Personal competencies
Independent clinical judgment; structured and pragmatic working style; scientific rigor; curiosity about new technologies; ability to work across specialties and prioritize competing requests; collaborative and constructive communication.
Note: Specific medical sign-off responsibilities depend on internal procedures, applicable regulatory requirements and individual qualifications.
- 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: Elisabeth Karro