Senior Manager - 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.
Stellenbeschreibung
- Define and lead the global Clinical Affairs strategy for Brainlab’s global surgery portfolio, ensuring alignment with product, regulatory and commercial objectives / teams
- Lead and develop an international Clinical Affairs team responsible for clinical evaluation, clinical research and scientific marketing communication
- Ensure clinical compliance with EU MDR, FDA and other regulatory requirements
- Build and maintain a strong clinical network of investigators, key opinion leaders and research partners
- Act as Process Owner for clinical evaluation and validation, training authors and evaluators to ensure regulatory compliance
- Partner closely with R&D, Product Management, Marketing, Sales and Quality Management on the strategy and to translate clinical insights into product innovation and market differentiation
- Bridge clinical research and scientific marketing by translating evidence into credible, high-impact scientific and educational content
- Ensure GDPR compliance in clinical collaborations
- Define and manage clinical studies and investigations to support product innovation and regulatory approvals
- Represent the company in communications with regulatory authorities related to clinical strategy, investigations and submissions
Qualifikationen
- Advanced scientific, medical or technical degree (PhD, MD, or equivalent preferred)
- Extensive experience in Clinical Affairs, Clinical Research within the medical device industry
- Strong background in clinical and regulatory requirements for Class I–III medical devices
- Demonstrated leadership experience, including managing international or cross-functional teams
- Several years of experience in Clinical Affairs, Clinical Research and/or R&D within the medical device industry
- Clinical and regulatory background for Class I to Class III medical devices
- 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
- Ability to translate clinical research into scientific marketing content
- Excellent stakeholder management, communication, and project leadership skills
- Solid understanding of GDPR and clinical data protection requirements
- Very good English skills, German is a plus
Weitere Informationen
- 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.