Clinical R&D Manager for Medical Devices

LINDERA; Berlin; Vor Ort; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

LINDERA seeks a Clinical R&D Specialist to innovate within AI-driven clinical frameworks, bridging the gap between clinical research and digital health solutions for elder care. Join our mission to enhance mobility and safety for aging populations through cutting-edge technologies. With a collaborative team environment and a focus on impactful healthcare outcomes, your expertise will drive significant advancements in clinical decision-making.

Leistungen

Innovative product development

Growth and autonomy in role

Flat hierarchy and open culture

Impact-driven team

Modern workspace in Berlin-Friedrichshain

Qualifikationen

• 3+ years in clinical research, preferably in digital health or medical devices.
• Experience with SaMD, ISO 14155, MDR, and CDS systems is a plus.
• Hands-on experience with real-world evidence projects.

Aufgaben

• Lead clinical studies compliant with GCP and MDR standards.
• Define decision-support logic for care and rehabilitation.
• Prepare clinical evidence for regulatory bodies and internal leadership.

Kenntnisse

Statistical analysis

Data analysis

Clinical methodology

Scientific writing

Regulatory compliance

Collaboration

English fluency

German fluency

Ausbildung

Degree in Biomedical Engineering

Degree in Digital Health

Degree in Rehabilitation Sciences

Tools

Electronic Data Capture (EDC)

AI motion analysis

Jobbeschreibung

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

About LINDERA:

LINDERA is an AI-driven medical device manufacturer, founded in 2017, specializing in motion analysis for older adults. Our mission is to empower mobility and independence in aging populations by tackling the urgent medical challenge of fall prevention. Our core innovation: AI-based 3D motion analysis using just a smartphone camera.

This breakthrough transforms complex gait analysis into an accessible tool for everyday clinical practice. Our CE-certified Software-as-a-Medical-Device (SaMD) already supports care professionals with actionable insights—bringing cutting-edge technology into real-world environments. Our work is validated in peer-reviewed journals (e.g., JMIR Aging 2024;7:e55681) and is already shaping care planning, mobility support, and prevention in care institutions across Europe.

Building on our AI-driven traffic light system for fall risk classification, LINDERA now expands its clinical roadmap to systematically define cut-off values and build Clinical Decision Support Systems (CDSS) based on AI-generated motion data. These systems aim to inform decisions across care levels (e.g. Pflegegrad in Germany), rehabilitation pathways (e.g. mobility aid comparison), and long-term safety monitoring in aging. This is where you come in.

Tasks

Role Overview:

We are looking for a Clinical R&D Manager to join our interdisciplinary team. You will lead the development of evidence-based clinical frameworks, integrating AI motion analysis with practical decision support systems. This role bridges clinical science, regulatory compliance, and digital health innovation—ideal for someone passionate about shaping the future of elder care through real-world data and smart clinical algorithms.

What You'll Achieve:

• Lead the clinical R&D Roadmap to define and validate motion-based cut-off values and decision-support logic for care, rehab, and geriatric safety.


• Design and manage clinical studies in compliance with GCP and MDR standards.


• Collaborate with Product, Data Science, and Engineering teams to translate clinical findings into product enhancements.


• Develop structured clinical content for Clinical Decision Support Systems (CDSS) based on LINDERA’s AI motion data.


• Prepare and present clinical evidence to regulatory bodies, clients, and internal leadership.


• Drive scientific publications and contribute to public grant proposals.


• Help standardize mobility assessment tools for digital care planning across Europe.

Requirements

What You Bring:

• A degree in Biomedical Engineering, Digital Health, Rehabilitation Sciences, or a related field.


• 3+ years of experience in clinical research, ideally in digital health or medical devices.


• Strong statistical and data analysis skills (e.g. R, Python) and a solid understanding of clinical methodology.


• Proven track record in scientific writing, grant applications, and regulatory submissions.


• Experience with SaMD, ISO 14155, MDR, and CDS systems is a strong plus.


• Hands-on experience with Electronic Data Capture (EDC) and real-world evidence projects.


• Fluency in English and German, both written and spoken.


• A strategic thinker who can translate clinical needs into product design and business impact.


• A collaborative mindset and a passion for turning healthcare data into meaningful action.

Benefits

What We Offer:

• Innovative Product & Purpose: Work at the forefront of AI and digital mobility assessment, with a direct impact on aging populations.


• Autonomy & Growth: Full ownership of your work and freedom to explore new clinical approaches within a supportive, agile team.


• Flat Hierarchy & Open Culture: We believe in open dialogue, fast iteration, and empowering every team member. You report directly to the CTO and work closely together with the Market Access team.


• Impact-Driven Team: Be part of a purpose-driven company where your work matters—both clinically and socially.


• Modern Workspace: Join us in the heart of Berlin-Friedrichshain with a vibrant office culture and top infrastructure.

Ready to move healthcare forward?

If you are excited to bring clinical depth into AI-based decision-making and want to shape the future of elder care, we would love to hear from you. Apply now and join us in building the future of safe mobility and digital healthcare!

LINDERA – Move safely, live happily.