Clinical R&D Manager for Medical Devices Innovations

vor 4 Wochen


Berlin, Berlin, Deutschland LINDERA GmbH Vollzeit

We are seeking a highly skilled Clinical R&D Manager to lead our medical device innovation efforts. As a key member of our team, you will be responsible for developing, executing, and optimizing clinical research activities, ensuring compliance with regulatory standards, and driving the enhancement of our AI-based fall prevention solutions.

Key Responsibilities
  • Lead research and development for the continuous improvement of our medical products
  • Conduct and oversee clinical studies, ensuring adherence to Good Clinical Practices (GCP) and MDR (Medical Device Regulation) standards
  • Collaborate with cross-functional teams, including Product, Data Science, and Engineering, to translate clinical findings into product enhancements
  • Manage the collection and analysis of data using electronic data capture (EDC) systems
  • Create and deliver clinical reports and recommendations to internal and external stakeholders
  • Participate in R&D projects, contributing to cutting-edge innovations in healthcare technology
Requirements
  • A degree in Biomedical Engineering, Digital Health, Rehabilitation Sciences, Health Sciences, or a related field
  • 3+ years of experience in clinical research and development
  • Strong understanding of biostatistics and data analysis methodologies, including proficiency in tools such as R or Python
  • Experience in scientific writing for peer-reviewed publications, public grants, reports, and regulatory submissions
  • Experience with medical devices, especially SaMD (Software as a Medical Device) is a plus, and a thorough understanding of MDR and GCP (ISO requirements
  • Proven experience with EDC systems and clinical research methodologies
  • Ability to conceptualize and contribute to product optimization efforts based on clinical evidence and feedback
  • Strong stakeholder management and decision-making skills
  • Experience reporting to senior leadership
  • A collaborative and proactive mindset with a passion for healthcare innovation
  • Excellent written and verbal communication skills in both English and German

LINDERA GmbH is a pioneer in addressing the critical challenge of fall prevention among the aging population through advanced Computer Vision AI technology. Our solution democratizes access to advanced gait analysis, allowing for accurate early detection of fall risks and personalized intervention strategies, ultimately improving the safety and quality of life for the elderly.

As a dynamic leader at the intersection of digital health innovation and practical application, you will be shaping the future of medical technology. If you are ready to contribute to the future of healthcare and bring your expertise to a leading-edge solution, we would love to hear from you.



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