Senior Regulatory Affairs Specialist

Senior Regulatory Affairs SpecialistWho We AreNeuroLogica, 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, NeuroLogica 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, NeuroLogica 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.Role DescriptionThis individual will be responsible for developing and implementing regulatory strategies, preparing and managing complex submissions and ensuring compliance with evolving global regulations and standards. The Senior Regulatory Specialist will act as a subject matter expert, providing strategic guidance to cross-functional teams and serving as a key liaison with global regulatory authorities and Notified Bodies. Essential Duties and Responsibilities. Other duties may be assignedManage 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 testingLead 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 managementBuild creative, scalable solutions for managing large image databases and supporting submission workflowsWork with, and respond to, inquiries from regulatory agencies including FDA, EU Notified Body, NMPA, PMDA, TGA, ANVISA and other national and regional health authoritiesSupport post-market surveillance, vigilance reporting, change assessmentsMonitor 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 MarketingMaintain dashboard for regulatory approvals for international country license / registration renewalsReview labeling and promotional materials to ensure consistency with regulatory approvalsLead cross functional teams with Product, Marketing, Engineering, Clinical to prepare and secure timely product approvals, clearance and registrationsProvide assistance and expertise during regulatory inspectionsPromote teamwork and collaboration within the regulatory function and with other functional areasAbility to create regulatory updates for Management Review MeetingCommunicate clearly (written and oral) with other company personnel, vendors, regulatory agencies, auditors, and the customer as requiredWork independently with minimal supervision and as part of team Keep knowledge of all NeuroLogica products up-to-dateFollow all company policies regarding training, travel, expenses, meetings, and mealsManage 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 devicesEducation & ExperienceBachelor’s in Regulatory, Engineering or related field preferred5 years of related experience in regulatory affairs Proven track record of authoring successful submissions of FDA 510(k)s CE Marking and other international registrationsManagement of AI-enabled medical devicesWorking with devices involving CT, X-Ray and Ultrasound.Regulatory Affairs Certification (RAC) preferredStrong knowledge of international medical device regulations (FDA, Health Canada, ANVISA, NMPA, CDSCO, TGA)Familiarity with AI/ML regulatory frameworks, cybersecurity and usability standardsAbility 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 deadlinesTechnically savvy; must be able to discuss, understand and author presentations, documentation and reportsExcellent written, oral, and documentation skillsIn compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hireComputer SkillsMust be able to assemble facts from various areas, analyze data, and provide informed recommendations to managementMust be able to work with minimal supervision, take charge of projects, and work effectively in a demanding, fast paced environmentMust 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 Physical RequirementsWorking flexible hours to accommodate global time zones Frequently required to sit; use hands to finger, handle, or feel; reach with hands; and talk or hearMust be able to sit for long periods of time The noise level in the work environment is usually mild.Specific vision abilities required by this job include Close vision, Distance vision, Peripheral vision, Depth perception and Ability to adjust focusInteraction 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 situationCompetenciesHigh attention to detailSkilled in leading teams, motivating staff and building quality culture.Ability to meet accuracy and productivity goalsGood problem solving skills, ability to evaluate situation and prioritize factors in decision makingSelf-motivated, utilize available resources for self-improvement and developmentFlexible: able to follow directives and accomplish tasks outside of normal duties About NeuroLogica, A Samsung CompanyLocated North of Boston in Danvers, MA, NeuroLogica Corporation, a subsidiary of Samsung Electronics, develops, manufactures and markets innovative medical imaging equipment for healthcare facilities and private practices worldwide. As a fast-moving, entrepreneurial company, NeuroLogica is a rapidly growing presence in the radiology field and is committed to delivering fast, easy and accurate imaging solutions to healthcare providers. We welcome you to learn more at: https://www.neurologica.comWe offer a comprehensive benefit package which includes;5 Different Blue Cross/Blue Shield Medical Plans to meet your needsDental coverage through BlueCross/Blue Shield DentalVision coverage by Blue Cross/Blue ShieldCompany paid Short-term and Long-term Disability coverage$1 for $1 401k match up to 5% managed by FidelityOther benefit options such as company paid employee life insurance, a wellness program, tuition reimbursement and many more! Please contact NeuroLogica if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment." Contact careers@neurologica.com for any questions or requests. NeuroLogica welcomes diversity and is an AA/EEO Employer – Minorities/Women/Veterans/Disabled and other protected categories are always encouraged to apply. The company’s AAP can be made available for inspections upon requests.

Salary : $33 - $41