Senior Regulatory Affairs Specialist

Role Description

Senior Regulatory Affairs Specialist role at Boston Imaging - A Samsung Company. Neuro Logica, a Samsung company, serves as the global headquarters and manufacturer for Samsung Healthcare’s Computed Tomography (CT) business, delivering innovative mobile CT solutions used in leading healthcare institutions worldwide. Our technologies help providers enhance patient care, improve satisfaction, and increase workflow efficiency across diverse clinical environments. As part of Samsung Healthcare USA, Neuro Logica works alongside Boston Imaging to deliver Samsung’s full portfolio of imaging solutions, including Computed Tomography, Ultrasound, and Digital Radiography.

Backed by the global strength of Samsung Electronics, we are advancing medical imaging at an unmatched rate of innovation, developing customer‑centric solutions quickly and with passion to address the real challenges clinicians face every day. Guided by a vision to make the world a healthier place, Neuro Logica empowers healthcare providers with technology that helps them diagnose more confidently, deliver care more quickly, and do so in a cost‑effective way.

By continually refining today’s solutions and accelerating the breakthroughs of tomorrow, Samsung Healthcare remains at the forefront of an ever‑evolving healthcare landscape.

• Manage end‑to‑end process AI‑enabled medical devices including data collection, model performance and monitoring on safety and effectiveness
• Work cross functionally to ensure all AI systems from large language models (LLMs) to multimodal architectures have appropriate data management practices for training, tuning and testing
• Lead the planning, preparation, and submission of regulatory dossiers, including FDA 510(k), De Novo, EU MDR Technical Documentation, Health Canada license applications, ANVISA, NMPA, CDSCO, TGA, and other international filings.
• Develop and execute regulatory strategies for new product development, AI/ML‑enabled imaging software, SaMD and legacy product lifecycle management
• Build creative, scalable solutions for managing large image databases and supporting submission workflows
• Work with, and respond to, inquiries from regulatory agencies including FDA, EU Notified Body, NMPA, PMDA, TGA, ANVISA and other national and regional health authorities
• Support post‑market surveillance, vigilance reporting, change assessments
• Monitor the regulatory environment.
  
  Stay abreast of changes in regulations throughout all major international geographies and disseminate new regulations and guidance to members of R&Q, Product, Engineering and Marketing
• Maintain dashboard for regulatory approvals for international country license / registration renewals
• Review labeling and promotional materials to ensure consistency with regulatory approvals
• Lead cross functional teams with Product, Marketing, Engineering, Clinical to prepare and secure timely product approvals, clearance and registrations
• Provide assistance and expertise during regulatory inspections
• Promote teamwork and collaboration within the regulatory function and with other functional areas
• Ability to create regulatory updates for Management Review Meeting
• 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
• Keep knowledge of all Neuro Logica products up-to-date
• Follow all company policies regarding training, travel, expenses, meetings, and meals
• Manage time effectively; prioritize and make good business judgments and decisions in relationship to efficiency, effectiveness
• Required to wear dosimeter when in direct contact with radiation emitting devices

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.

• Bachelor’s in Regulatory, Engineering or related field…