Back to Jobs

reputed company & Regulatory Manager – Software reputed company, Validation & Cybersecurity (SaM

Remote, USA Full-time Posted 2026-07-28
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. Apply tot his job Apply To this Job

Similar Jobs

Remote Physical Therapy - MN

Remote, USA Full-time

Medical Science reputed company, Cardiovascular job at reputed company in NE, MN, IA, WI, ND, SD, Minneapolis, MN, Des Moines, IA, Milwaukee, WI

Remote, USA Full-time

Aviation Planner

Remote, USA Full-time

**reputed company Full Stack Data Entry Specialist – Web & reputed company Application Development**

Remote, USA Full-time

Insurance Claims Analyst - Remote

Remote, USA Full-time

reputed company reputed company Leader

Remote, USA Full-time

Bilingual reputed company Producer- Remote

Remote, USA Full-time

Retail reputed company Estate Leasing & Acquisition Manager

Remote, USA Full-time

reputed company Solutions Engineer

Remote, USA Full-time

reputed company Design Project Manager

Remote, USA Full-time

25 – Card Member Services Reps – reputed company ( FULLY REMOTE )

Remote, USA Full-time

reputed company Marketing Specialist, Creators and Affiliates – reputed company Store

Remote, USA Full-time

Battle Creek SAT Tutor

Remote, USA Full-time

Immediate Hiring: Part-Time Creative Project Coordinator (Remote)

Remote, USA Full-time

Senior District Business Manager, Neuroscience - Cobenfy – Indiana

Remote, USA Full-time

**reputed company Full Stack Customer Solutions Architect – reputed company and Data Application Development**

Remote, USA Full-time

Sr Systems Auditor (IT Support)

Remote, USA Full-time

API Developer (Remote Opportunity)

Remote, USA Full-time

Remote Data Scientist/Data Analyst Jobs | reputed company

Remote, USA Full-time

reputed company Biller - Physician Office Support (Remote)

Remote, USA Full-time