Job Description
Location: Danvers, MA Who We Are Samsung HME America (Healthcare and Medical Equipment) is Samsung’s U.S. medical imaging organization, delivering advanced diagnostic solutions across Ultrasound, Digital Radiography, and Computed Tomography. We lead nationwide sales, marketing, service, and distribution of Samsung’s imaging technologies, partnering with healthcare providers to strengthen diagnostic capabilities, streamline clinical workflows, and support better patient care. Samsung HME America also serves as the global manufacturing center for Samsung’s mobile Computed Tomography (mCT) business, leading the development of advanced CT systems used by healthcare providers worldwide. Backed by Samsung Electronics’ global technology leadership, our teams work closely with clinicians to translate real-world challenges into innovative imaging solutions. Our culture combines a sense of urgency, customer focus, and clinical collaboration to advance the future of medical imaging. Role Description The AI Regulatory Manager will be the principal architect of regulatory strategy and execution for our AI/ML-enabled imaging and software-as-a-medical-device (SaMD) portfolio catering to ultrasound, CT, and digital X-ray medical devices. This individual will be responsible for developing and implementing regulatory strategies, preparing and managing complex submissions and ensuring compliance with evolving global regulations and standards. Key Duties And Responsibilities, Other Duties May Be Assigned Lead the end-to-end regulatory lifecycle for AI-enabled medical devices, including data collection, model performance evaluation, safety and effectiveness monitoring, and post-market surveillance. Define and implement regulatory strategies for AI/ML-driven imaging software, SaMD, and legacy imaging products, across all stages from concept to post-market. Partner with Product, Marketing, Engineering, Clinical to prepare and secure timely product approvals, clearance and registrations Oversee planning, preparation, and submission of regulatory dossiers, including FDA 510(k), EU MDR Technical Documentation, Health Canada, ANVISA, NMPA, CDSCO, TGA, and other international filings. Maintain dashboards for global regulatory approvals, license and registration renewals, labeling and promotional material compliance, and support management review and strategic planning. Provide assistance and expertise during regulatory inspections Build and maintain scalable frameworks for managing large imaging- and data-sets (training, tuning, test sets), regulatory documentation, and submission workflows. Mentor, coach, and manage junior regulatory and AI-staff; build regulatory-AI competence within the organization. Communicate clearly (written and oral) with other company personnel, vendors, regulatory agencies, auditors, and the customer as required Work independently with minimal supervision and as part of team Maintain current knowledge of Samsung HME America products Qualifications and Requirements: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Education & Experience Bachelor’s in Regulatory, Engineering or related field preferred 8+ years of progressive regulatory affairs experience in medical devices, with at least 3–5 years directly managing AI/ML–enabled imaging software or SaMD product regulatory work. Proven track record of authoring successful submissions of FDA 510(k)s CE Marking and other international registrations Management of AI-enabled medical devices Working with devices involving CT, X-Ray and Ultrasound. Strong knowledge of global medical device regulations — FDA, EU MDR, ISO 13485, and relevant standards for AI/ML software, cybersecurity, usability, and post-market Regulatory Affairs Certification (RAC) preferred Ability to communicate effectively with engineers, marketing, and management through all media Strong organizational and project management skills, with the ability to manage multiple priorities and deadlines Technically savvy; must be able to discuss, understand and author presentations, documentation and reports Excellent written, oral, and documentation skills Computer & Analytical Skills Must be able to assemble facts from various areas, analyze data, and provide informed recommendations to management Must be able to work with minimal supervi