Senior Medical Device Innovation Specialist
Vor 7 Tagen
As a Senior Medical Device Innovation Specialist at LINDERA GmbH, you will play a key role in developing, executing, and optimizing clinical research activities for our AI-based fall prevention solutions.
Job DescriptionWe are looking for an experienced professional to lead research and development for the continuous improvement of our medical products. This includes conducting and overseeing clinical studies, ensuring adherence to Good Clinical Practices (GCP) and MDR (Medical Device Regulation) standards.
You will collaborate with cross-functional teams to translate clinical findings into product enhancements and manage the collection and analysis of data using electronic data capture (EDC) systems.
Your responsibilities will also include creating and delivering clinical reports and recommendations to internal and external stakeholders, as well as participating in R&D projects to contribute 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
- Innovative and Unique Product: Contribute to the development of patented AI-driven 3D motion analysis technology, shaping 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: Enjoy autonomy to shape your goals and projects, taking full responsibility for your work after a comprehensive onboarding period
- LINDERA Values: Cultivate respect, teamwork, and solution-oriented thinking in everything we do
- Modern Infrastructure: Benefit from a state-of-the-art work environment in our design office in the heart of Friedrichshain, with excellent connectivity and a vibrant atmosphereSalary and Location
The estimated salary for this position is €70,000 - €90,000 per year, depending on experience. The location is Berlin, Germany.
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