Clinical Affairs Medical Expert (MD)

Brainlab; München; Hybride; EUR 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Hybrid work model in Germany

Bike leasing via BikeLeasing

Company restaurant benefit

Gym access

Training & development

30 vacation days

Résumé du poste

Brainlab is seeking a medically qualified Clinical Expert to provide independent medical input across our image-guided surgery, planning and imaging technologies. The role blends clinical evaluation with practical advice to R&D, Product Management, Regulatory Affairs and QA.

You will support multiple clinical domains including cranial, spine & trauma, ENT, CMF and general surgery. Responsibilities include evaluating CEPs/CERs and literature, shaping clinical evidence plans, and translating

Qualifications

• MD or equivalent medical degree with hands-on patient care experience.
• Clinical practice in neurosurgery, ENT, CMF, spine or related fields.
• Strong understanding of clinical workflows and evidence-based medicine.
• Ability to evaluate clinical documentation and provide sound medical judgments.
• Excellent written and spoken English; cross-functional collaboration.

Responsabilités

• Serve as Clinical Advisor for Brainlab portfolios.
• Review CEPs, CERs, SOTA reviews, and design validation strategies.
• Critically evaluate literature and clinical evidence across product lifecycles.
• Contribute to PMS, PMCF plans and post-market evidence strategies.
• Advise R&D, Product Management, Regulatory and QA on clinical needs.
• Collaborate with external clinicians and key opinion leaders.
• Support development of clinical training and scientific content.
• Translate clinical practice into actionable product improvements.

Connaissances

MD/medical degree

Clinical practice

Clinical workflows

Evidence-based medicine

Cross-functional collaboration

English proficiency

Formation

MD or equivalent

Description du poste

At the forefront of health technology for over 35 years, Munich-based Brainlabdigitizesmedical 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,talentedand 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,authenticand useful.

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.

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