Clinical R&D Manager for Medical Devices (m/w/d)

Stellenbeschreibung

We are looking for a Clinical R&D Specialist. Lead AI fall prevention research, ensure compliance, innovate. Medical Device expertise required.

About LINDERA:

LINDERA, founded in 2017, is a pioneer in addressing the critical challenge of fall prevention among the aging population through advanced Computer Vision AI technology. Despite progress in elder care, falls remain a leading cause of injury among seniors, leading to decreased mobility, loss of independence, and a heavy burden on healthcare systems. Traditional methods for assessing fall risk often require specialized equipment and expertise, limiting their accessibility.

At LINDERA, we (r)evolutionize fall prevention by leveraging AI-driven 3D motion analysis, utilizing everyday smartphone cameras to analyze gait parameters. 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, we are shaping the future of medical technology.

Tasks

We are looking for a Clinical R&D Specialist to join our team. You will play a key role in developing, executing, and optimizing clinical research activities, ensuring compliance with regulatory standards, and driving the enhancement of our AI-based fall prevention solutions. This position requires a blend of clinical expertise, experience with medical device regulations, and the ability to collaborate on innovative product development strategies.

What You'll Achieve:

• 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 14155) 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

Benefits

• Innovative and Unique Product: Be a pioneer in the healthcare field with LINDERA’s patented AI-driven 3D motion analysis technology. Help shape the digital future of elder care.
• Effective Structures & Open Communication: Work in an agile, flat hierarchy that fosters innovation, continuous learning, and cross-team collaboration.
• Diverse & Challenging Role: Join a dynamic healthcare market where every day presents new challenges and opportunities for professional growth.
• Ownership & Responsibility: After a comprehensive onboarding period, you will have the autonomy to shape your goals and projects, taking full responsibility for your work.
• LINDERA Values: We maintain a strong sense of who we are, cultivating respect, teamwork, and solution-oriented thinking in everything we do.
• Modern Infrastructure: Enjoy a state-of-the-art work environment in our design office in the heart of Friedrichshain, with excellent connectivity and a vibrant atmosphere.

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. Please submit your application today and join the LINDERA team in shaping the future of elder care.

LINDERA – Move safely, live happily!

Kontakt

LINDERA GmbH