Clinical RD Manager for Medical Devices
vor 2 Wochen
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 AIdriven 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.
TasksWe 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 AIbased 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 Youll 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 crossfunctional 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 cuttingedge innovations in healthcare technology
- 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 peerreviewed 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 decisionmaking 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
- Innovative and Unique Product: Be a pioneer in the healthcare field with LINDERAs patented AIdriven 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 crossteam 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 solutionoriented thinking in everything we do.
- Modern Infrastructure: Enjoy a stateoftheart 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 leadingedge 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
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