Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist
Posted on :
12-09-2025
Employer Active
1 Vacancy
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Share
Send me jobs like this
Job Alert
You will be updated with latest job alerts via emailValid email field required
Send jobs
Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
12-09-2025
Job Description
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 2015 NeuroLogica became the US headquarters for all of Samsung Health and Medical 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 peoples 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
- Bachelors 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
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:.
We offer a comprehensive benefit package which includes;
- 4 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!
NeuroLogica welcomes diversity and is an AA/EEO Employer Minorities/Women/Veterans/Disabled and other protected categories are always encouraged to apply.
Required Experience:
Senior IC
Employment Type
Full-Time
Key Skills
Report This Job
Disclaimer: Drjobpro.com is only a platform that connects job seekers and employers. Applicants are advised to conduct their own independent research into the credentials of the prospective employer.We always make certain that our clients do not endorse any request for money payments, thus we advise against sharing any personal or bank-related information with any third party. If you suspect fraud or malpractice, please contact us via contact us page.
