Boston Imaging - A Samsung Company · 2 months ago
Senior Regulatory Affairs Specialist
Danvers, MA, US
Full-time
Onsite
Senior Level
5+ years expBoston Imaging, a subsidiary of Samsung, is a leader in innovative medical imaging solutions. The Senior Regulatory Affairs Specialist will develop and implement regulatory strategies, manage submissions, and ensure compliance with global regulations in the healthcare sector.
Health CareMarketingWholesale
Responsibilities
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
Required to wear dosimeter when in direct contact with radiation emitting devices
Qualification
Required
5+ years of related experience in regulatory affairs
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 international medical device regulations (FDA, Health Canada, ANVISA, NMPA, CDSCO, TGA)
Familiarity with AI/ML regulatory frameworks, cybersecurity and usability standards
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
In 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 hire
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
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
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 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
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
Preferred
Bachelor's in Regulatory, Engineering or related field preferred
Regulatory Affairs Certification (RAC) preferred
Benefits
5 Different Blue Cross/Blue Shield Medical Plans to meet your needs
Dental coverage through BlueCross/Blue Shield Dental
Vision coverage by Blue Cross/Blue Shield
Company paid Short-term and Long-term Disability coverage
$1 for $1 401k match up to 5% managed by Fidelity
Other benefit options such as company paid employee life insurance, a wellness program, tuition reimbursement and many more!
Company
Boston Imaging - A Samsung Company
Boston Imaging, A Samsung Company, serves as the U.S.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase