Quality & Regulatory Affairs Manager (m/f/d) – MedTech Startup (Berlin | Start: Q4 2025) About Us At UniWearables (www.uniwearables.com), we are developing a highly-innovative clinical wearable system ( Class IIa under MDR ) for continuous vital sign monitoring on general wards. Our matchbox-sized sensor captures essential physiological parameters in real time – a game-changing improvement over the current standard, where vital signs are manually recorded in time-consuming spot checks. Early signs of patient deterioration often go unnoticed. Our system enables continuous monitoring, alleviates nursing workload, and lays the foundation for AI-driven prediction and screening models. We collaborate closely with leading scientists and physicians, including partners at Charité – Universitätsmedizin Berlin and the Center for Space Medicine & Extreme Environments. Our vision is to revolutionize patient monitoring and help patients return home faster and safer. Your Responsibilities Prepare, maintain, and submit technical documentation in accordance with EU MDR (Regulation EU 2017/745) Develop and implement regulatory strategies for wearable and telemonitoring medical devices Ensure compliance with all relevant EU and international regulations Support the setup and ongoing maintenance of our ISO 13485-compliant Quality Management System (QMS) Prepare and support audits by Notified Bodies and Competent Authorities Collaborate cross-functionally with product development, clinical research, software, and external partners Communicate and coordinate with Notified Bodies, authorities, and external regulatory service providers Contribute to international regulatory submissions (e.g., FDA 510(k) ) Your Profile Degree in Biomedical Engineering, Life Sciences, Regulatory Affairs, or a related field Minimum 3 years of relevant experience in Regulatory Affairs for medical devices Strong knowledge of EU MDR and relevant standards (e.g., ISO 14971, ISO 62366, ISO 60601 ) Proven experience in preparing compliant technical documentation and translating regulatory requirements into practice Experience with wearables or telemedicine applications is a plus Solid understanding of ISO 13485 QMS, including implementation and auditing Experience with FDA submissions (510(k)) is highly desirable Excellent written and spoken English and German Proactive, structured, and independent working style Available to start: Q4 2025 Location: Berlin Full-time ( 4-5 days /week) What We Offer The opportunity to work on a mission-driven, high-impact product A competitive annual salary A dynamic startup environment with exceptional talent, including successful entrepreneurs and top-tier researchers and clinicians Flat hierarchies, ownership, and real contribution to innovation in patient care Ready to shape the future of medical technology with us? We’re looking forward to your application at contact@uniwearables.com or feel free to contact us directly on LinkedIn.