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0Clinical Affairs Specialist (Medical Devices)
18 de febr.ABLE Human Motion
Barcelona, ES
Clinical Affairs Specialist (Medical Devices)
ABLE Human Motion · Barcelona, ES
Python R MATLAB
Clinical Affairs Specialist (Medical Devices)Location: Barcelona, Spain
About Us: We are a pioneering start-up that creates lightweight, quick-to-adjust, and accessible robotic exoskeletons.
Our mission is to democratize access to this technology, improving the rehabilitation, health and quality of life of millions of people with mobility impairments.
We are seeking a passionate team member to work on our clinical research efforts, ensuring our products deliver measurable and meaningful benefits to patients.
Position Overview: As a Clinical Affairs Specialist, you will play a critical role in designing and managing clinical trials to gather evidence that demonstrates the efficacy of our robotic exoskeletons.
You will work closely with the Product, Clinical and Regulatory Affairs teams to ensure compliance, reliability, and scientific rigor of clinical activities at ABLE Human Motion.
Key Responsibilities: Clinical Trials: Design clinical trial protocols to evaluate the benefits of our robotic exoskeletons, cooperating with external partners (clinical investigators from hospitals).Clinical Evidence & Data Analysis: Analyze clinical trial data using statistical methods to draw meaningful insights.
Then, incorporate these analyses into the clinical evaluation documentation for the device (clinical evaluation report).Clinical Trial Site Management: Create and maintain any documentation associated with clinical trials, including protocols, case report forms, and investigator brochures.Site Monitoring: Communicate and work closely with clinical investigators to ensure adherence to protocols, regulatory requirements, and high-quality data collection.Scientific Communication: Collaborate with clinical investigators to prepare scientific manuscripts, posters and congress/conference presentations to share the findings.Literature Review: Design and conduct systematic literature searches to integrate the latest evidence in rehabilitation robotics into our clinical evaluation and protocols.Requirements: Degree in Life Sciences, Biomedical Engineering, Medicine, Physiotherapy or related.Previous clinical research experience, preferably within medical devices or rehabilitation.Excellent scientific writing and communication skills.Attention to detail and strong analytical abilities.Proficiency with statistical analysis (MATLAB, R or Python).Have a valid permit to work in the European Union.Proficiency in written and oral English.Preferred: Knowledge of medical device clinical evaluation regulatory requirements (Medical Devices Regulation, EU MDR) or previous experience in a regulated industry is highly desirable.Familiarity with Good Clinical Practices (GCP), ISO 14155 and ethical considerations.Flexible working hours, with the option of telework 2 days a week.Full-time contract of employment.How to Apply? Send an email to ****** attaching your CV with the subject "Clinical Affairs Specialist".
Seniority LevelEntry level
Employment TypeFull-time
Job FunctionHealth Care Provider
IndustriesMedical Equipment Manufacturing
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