Quality & Regulatory Manager – Software Quality, 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 real-time fluoroscopy with pre-procedure 3D CT annotations to provide precise intra-procedural guidance, enhancing safety and clinical outcomes.
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 quality and regulatory professional with strong software testing/validation skills to own our Quality 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 quality system (procedures + records), supports FDA expectations under the Quality Management System Regulation (QMSR), and drives software verification & validation (V&V), release readiness, and post-market quality/cybersecurity activities.
Cara Medical (https://www.cara-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. Cara received Breakthrough Device designation from the FDA, as well as FDA clearance to market the device in the US. We are currently running clinical studies in sites in Europe, North America, Australia and Asia.
Cara is looking to hire a Quality & 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 well as a track record in working remotely and in a start up environment.
We are currently expanding our team. As a start-up, we are fast paced and have a shared goal to succeed in developing unmet healthcare needs in the most efficient way. If you share this vision and are interested in joining us - please apply. We look forward to hearing from you.
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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 quality and regulatory professional with strong software testing/validation skills to own our Quality 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 quality system (procedures + records), supports FDA expectations under the Quality Management System Regulation (QMSR), and drives software verification & validation (V&V), release readiness, and post-market quality/cybersecurity activities.
Cara Medical (https://www.cara-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. Cara received Breakthrough Device designation from the FDA, as well as FDA clearance to market the device in the US. We are currently running clinical studies in sites in Europe, North America, Australia and Asia.
Cara is looking to hire a Quality & 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 well as a track record in working remotely and in a start up environment.
We are currently expanding our team. As a start-up, we are fast paced and have a shared goal to succeed in developing unmet healthcare needs in the most efficient way. If you share this vision and are interested in joining us - please apply. We look forward to hearing from you.
Apply tot his job
Apply To this Job