Clinical Affairs Medical Expert (MD)

Employment: Full-time Experience level: Mid-Senior Level Job Description 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.  Qualifications 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.  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.  Contact person: Elisabeth Karro Company Description At the forefront of health technology for over 35 years, Munich-based Brainlab digitizes medical workflows, from diagnosis to therapy, to offer clinicians and patients better treatment possibilities. Our innovative digital ecosystem forms the basis for modern healthcare technology in 4000 hospitals in 120 countries.   Our key to success is our creative, talented and hard-working team, which consists of around 2000 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.