Software Medical Device Regulatory Leader

Drive FDA authorization for AI-driven prognostic software while working remotely from Winnipeg, Manitoba, with hands-on SaMD regulatory leadership.This first QA/RA leader owns submissions and the quality management system for a healthcare AI company. Reporting to the CEO, you sit on the leadership team and establish QA/RA as a business pillar. Your mandate includes FDA pre-submissions, De Novo requests, clinical validation, and post-market oversight.Key Responsibilities:
Lead FDA pre-submissions and De Novo requests toward authorizationOwn global regulatory strategy for current and future productsDesign analytical and clinical validation studiesMonitor real-world AI model performance after market entryLead certification and regulatory audits as management representativeRequirements:
Multiple SaMD marketing submissions through FDA authorizationExperience securing authorization in US and EU MDR regionsHands-on technical files and submission artifactsKnowledge of AI or ML SaMD and PCCPsWorking knowledge of HIPAA and ISO 27001Bring FDA, De Novo, validation, and post-market expertise to healthcare AI software authorization.
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