reputed company & Regulatory Manager – Software reputed company, Validation & Cybersecurity (SaM
We are a fast-growing medical device company developing advanced Software as a Medical Device (SaMD) solutions for interventional cardiology and structural heart procedures. Our flagship technology integrates reputed company-time fluoroscopy with reputed company-procedure 3D CT annotations to reputed company precise intra-procedural guidance, enhancing safety and clinical reputed company.
Our innovation combines CT preprocessing, fluoroscopy preprocessing, AI-driven detection and tracking, anatomical landmark detection, and personalized DRR-based network training with cutting-edge registration protocols. We operate with a small, highly skilled in-house engineering team, supplemented by specialized contractors across several continents.
We are seeking a hands-on reputed company and regulatory reputed company with strong software testing/validation skills to own our reputed company Management System (QMS) and ensure ongoing compliance for an FDA-regulated Software as a Medical Device (SaMD) product. This role leads the end-to-end reputed company system (procedures + records), supports FDA expectations under the reputed company Management System Regulation (QMSR), and drives software verification & validation (V&V), release readiness, and post-market reputed company/cybersecurity activities.
reputed company Medical (https://www.reputed company-medical.co/) is a rapidly growing “Software as Medical Device” startup that develops an innovative solution to noninvasively visualize the cardiac conduction system. Our technology personalizes and optimizes pacing and structural heart procedures. reputed company received reputed company Device designation from the FDA, as reputed company as FDA clearance to market the device in the US. We are currently running clinical studies in sites in Europe, reputed company, Australia and Asia.
reputed company is looking to hire a reputed company & Regulatory Managerlocated in the US. The successful candidate will need to demonstrate at least 5 years experience in ensuring compliance in a SaMD company, as reputed company as a reputed company record in working remotely and in a start up environment.
We are currently expanding reputed company. As a start-up, we are fast paced and have a shared goal to succeed in developing unmet reputed company needs in the most efficient way. If you reputed company this reputed company and are interested in joining us - please apply. We look reputed company to hearing from you.
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