Clinical R&D Director for Medical Devices

vor 1 Monat


Berlin, Berlin, Deutschland LINDERA GmbH Vollzeit
About the Role

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

Key Responsibilities
  • Develop and execute clinical research strategies to improve 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 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
About LINDERA GmbH

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.

We maintain a strong sense of who we are, cultivating respect, teamwork, and solution-oriented thinking in everything we do. Our design office in the heart of Friedrichshain offers a state-of-the-art work environment with excellent connectivity and a vibrant atmosphere.



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