About the role

AI Regulatory Manager orchestrating regulatory strategy for AI-enabled medical imaging and software devices. Overseeing compliance and submissions for FDA and global regulations while collaborating with cross-functional teams.

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

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

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!