AI Regulatory Manager

Samsung HME America Inc • Danvers, MA

4h

About The Position

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.

Requirements

• 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
• Must be able to assemble facts from various areas, analyze data, and provide informed recommendations to management
• Must be able to work with minimal supervision, take charge of projects, and work effectively in a demanding, fast paced environment
• Must be excellent with technology, be able to present using a laptop computer, and be able demonstrate proficiency with MS Office package, including Excel, Word, and PowerPoint, as well as Outlook
• High attention to detail
• Skilled in leading teams, motivating staff and building quality culture.
• Ability to meet accuracy and productivity goals
• Good problem solving skills, ability to evaluate situation and prioritize factors in decision making
• Self-motivated, utilize available resources for self-improvement and development
• Flexible: able to follow directives and accomplish tasks outside of normal duties
• Working flexible hours to accommodate global time zones
• Frequently required to sit; use hands to finger, handle, or feel; reach with hands; and talk or hear
• Must be able to sit for long periods of time
• Specific vision abilities required by this job include Close vision, Distance vision, Peripheral vision, Depth perception and Ability to adjust focus
• Interaction with x-ray devices; for this reason strict safety and tracking programs are in place, requiring the utilization of dose monitoring equipment either full time or as necessitated by situation

Responsibilities

• 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

Benefits

• Medical (Blue Cross Blue Shield): 5 PPO Plans (with up to 95% employer contribution)
• Dental (Blue Cross Blue Shield): 2 PPO Plans (with up to 80% employer contribution)
• Vision (Blue Cross Blue Shield): 100% company paid
• Short/Long Term Disability, Life & AD&D (The Standard): 100% company paid
• 401k Retirement (Fidelity): 100% company match up to 5%
• Tax Deferred Health Care Savings Programs
• Accident Insurance, Critical Illness, Hospital Indemnity, Pet, Legal, ID Theft
• Generous paid time off, tuition reimbursement, and more!

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 1-10 employees