SVP, Global Regulatory Affairs

Radiology Partners

3d • Remote

About The Position

Mosaic Clinical Technologies™ is pioneering a new imaging paradigm—shifting radiology from reactive diagnostics to proactive, decision-driven care. Through our AI-native platform, MosaicOS™, we unite fragmented technologies into a single, intelligent ecosystem designed to help clinical teams work faster, think smarter and deliver better care. Built cloud-native and designed for continuous iteration, MosaicOS™ is engineered to solve the industry’s most pressing challenges. Our platform expands clinical capacity, improves diagnostic quality by combining human expertise with AI, and turns operational complexity into strategic advantage through seamless integration or replacement of legacy imaging systems. Every AI tool within MosaicOS™ is validated across tens of millions of exams to ensure safe, reliable and meaningful clinical impact. With a ransomware-resistant design and built-in redundancy, our platform is designed to ensure continuity of care and protect both patients and operations. Mosaic Clinical Technologies™ is building technology that evolves with clinicians to advance clinical excellence and improve patient outcomes. If you’re passionate about shaping the future of medical imaging, join us! POSITION SUMMARY: Define and execute global regulatory strategies for AI‑powered SaMD products, including new launches, feature updates, and lifecycle management Lead global submissions and regulatory interactions (FDA 510(k)/De Novo/PMA, EU MDR/CE, UKCA, Health Canada, TGA, PMDA, and other international authorities) Serve as primary liaison with regulatory agencies, managing audits, inquiries, and negotiations Provide regulatory guidance to cross‑functional teams on design controls, risk management, software lifecycle, cybersecurity, and AI/ML regulations Build, scale, and mentor a high‑performing regulatory function while overseeing post‑market surveillance and compliance programs

Requirements

• 15+ years of medical device regulatory affairs experience, including 5+ years in SaMD or diagnostic imaging software
• Proven leadership of global regulatory submissions (FDA, MDR/CE, UKCA, TGA) for software‑based medical devices
• Deep expertise in key standards and frameworks (21 CFR 820, ISO 13485, IEC 62304, ISO 14971, AI/ML regulatory guidance)
• Hands‑on experience scaling compliance programs, including ISO audits, SOC 2 readiness, and enterprise assurance
• Strong executive‑level communication skills with the ability to operate strategically and tactically in a high‑growth environment

Responsibilities

• Define and execute global regulatory strategies for AI‑powered SaMD products, including new launches, feature updates, and lifecycle management
• Lead global submissions and regulatory interactions (FDA 510(k)/De Novo/PMA, EU MDR/CE, UKCA, Health Canada, TGA, PMDA, and other international authorities)
• Serve as primary liaison with regulatory agencies, managing audits, inquiries, and negotiations
• Provide regulatory guidance to cross‑functional teams on design controls, risk management, software lifecycle, cybersecurity, and AI/ML regulations
• Build, scale, and mentor a high‑performing regulatory function while overseeing post‑market surveillance and compliance programs

Benefits

• Competitive Benefits package – Eligibility starts the month after hire, with tiered options to choose from
• Compensation Reviews
• Career Growth Opportunities
• Flexible Remote Schedules
• Generous PTO Plans
• Paid Holidays

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: No Education Listed
• Number of Employees: 501-1,000 employees