Clinical Evaluation Specialist - Rehabilitation Technology

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Job Title: Clinical Documentation Specialist - Rehabilitation TechnologyCompany Description: Join our client, a global leader in advanced rehabilitation technology since 2007, and be part of their mission to revolutionize human movement therapy through innovative technologies. With a strong commitment to improving the lives of millions of patients worldwide, they specialize in developing, manufacturing, and marketing robotic and sensor-based devices for functional movement therapy. Their pioneering work has gained recognition in top-tier hospitals, cutting-edge neuro-rehabilitation facilities, and outstanding clinics across the globe.Job Description: As a Clinical Documentation Specialist, you will play a crucial role in ensuring the accurate and comprehensive documentation of clinical data and evidence for regulatory submission initiatives. Your expertise will contribute to obtaining early regulatory approvals for medical devices, ultimately making a difference in the field of rehabilitation therapy.Responsibilities

• Direct and oversee short-term and long-term planning of clinical data acquisition for regulatory submission initiatives.
• Lead pre-market clinical investigations and post-market clinical follow-up of medical devices, with a focus on early regulatory approvals.
• Collaborate with internal clinical experts, external partners, and research teams to design clinical data collection strategies.
• Analyze collected data and supervise the execution of clinical studies.
• Plan and conduct clinical evaluations of medical devices in compliance with regulatory requirements such as MDR and FDA guidelines.
• Prepare thorough responses to regulatory inquiries regarding clinical evidence and claims of medical devices.
• Review, evaluate, and compile clinical files and reports for regulatory submissions.

Required Qualifications

• Advanced degree in physiotherapy, occupational therapy, medicine, rehabilitation, human movement sciences, or a related discipline with relevance to neurorehabilitation.
• Professional experience in clinical practice, clinical affairs, medical affairs, or rehabilitation research.
• Experience conducting clinical evaluations for medical devices and providing regulatory guidance throughout the product development lifecycle in neurorehabilitation.
• Proven ability to negotiate with external agencies on regulatory issues related to clinical evidence and claims of medical devices.
• Strong clinical knowledge in neurorehabilitation.
• In-depth understanding of MDR, FDA regulations, and Good Clinical Practice.
• Fluency in English and German.

Join our client’s dynamic organization and contribute to transforming the landscape of rehabilitation therapy through meticulous documentation and clinical evidence. Your work will directly impact the lives of countless patients worldwide and shape the future of rehabilitation technology.If the above information aligns with you as a professional, then make sure you apply below, and let’s start to discuss shaping your future for the better. The role is now live and taking in multiple applicants each day so be sure to do so as quickly as possible. Don’t miss out on this opportunity, apply now!For further details, please don’t hesitate to reach out and contact Billy O’Brien, through the below channels, who is more than happy to answer any questions you may have!Mr. Billy O’BrienPhone: 0049 892 109 3369E-Mail: b.obrien@nonstop-recruitment.comLinked in: https://www.linkedin.com/in/billy-o-brien-07317123a