Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

WHO WE ARE :

NeuroLogica Corp., a subsidiary of Samsung Electronics Co. Ltd., develops, manufactures, and markets innovative imaging technologies and is committed to delivering fast, easy, and accurate diagnostic solutions to healthcare providers. NeuroLogica is the global corporate headquarters and manufacturer of mobile computed tomography, and is also the US headquarters for sales, marketing, service and distribution of all Samsung digital radiography and ultrasound systems. Our advanced medical technologies are used worldwide in leading healthcare institutions, helping providers enhance patient care, improve patient satisfaction, and increase workflow efficiency. Samsung is committed to being a leader in the field of healthcare imaging.

Samsung is a growing presence in the radiology field and is committed to delivering fast, easy and accurate imaging solutions to healthcare providers. In 2015, NeuroLogica became the US headquarters for all of Samsung Health and Medical Equipment. The full range of Samsung imaging solutions includes Ultrasound, Digital Radiography, and mobile Computed Tomography (mCT). Samsung aims to become a global leader in the medical imaging space and is investing heavily in developing innovative, advanced imaging technologies that will improve the quality of people's lives.

Samsung keeps a constant eye on the always-evolving, ever-changing imaging industry. By continually enhancing current product lines and seeking to develop new technologies, Samsung is at the forefront of the imaging frontier.

ROLE DESCRIPTION :

Responsible for leading and executing global regulatory submissions and compliance activities for our innovative portfolio of ultrasound, AI-enabled imaging, CT, and digital X-ray medical devices.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned

• 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 NeuroLogica 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

EDUCATION & EXPERIENCE

COMPUTER & ANALYTIC SKILLS

PHYSICAL REQUIREMENTS

COMPETENCIES

About NeuroLogica

Located 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.com .

We offer a comprehensive benefit package which includes;

NeuroLogica welcomes diversity and is an AA / EEO Employer Minorities / Women / Veterans / Disabled and other protected categories are always encouraged to apply.

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