Senior Regulatory Affairs Specialist

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

• Bachelor’s in Regulatory, Engineering or related field preferred
• 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
• Post-market regulations and requirements for medical devices
• Working with devices involving CT, X-Ray and Ultrasound.
• Regulatory Affairs Certification (RAC) preferred. 
• 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

COMPUTER & ANALYTIC SKILLS

• 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 

PHYSICAL REQUIREMENTS

• Occasionally lift and /or move up to 25 pounds
• 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

COMPETENCIES

• High attention to detail
• Understanding of terminology and ability to share and communicate effectively within the group
• Ability to organize and prioritize tasks resulting in consistent productivity
• Ability to function within and support a team environment and build strong working relationships
• Dependable and punctual
• 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