Young Geun Kim

• 2022.05 – Current: iMediSync RQA Lead & QMR, Clinical, SQA, Hardware Development PM
• 2022.06: Ministry of Food and Drug Safety Task – Selection of Usability (Seoul National University Hospital) (approximately KRW 50 million)
• 2022.08: FDA 510(k) of iSync Wave
• 2022.09: Selection of overseas certification acquisition support project (100 million won)
• 2022.10: Acquisition of KGMP following plant relocation
• 2022.11: ISO13485:2016 GMP (brainwave system) obtained
• 2022.12: Performance Test by Gwangju Techno Park
• TTA Test for iSyncBrain-C (Brainwave Analysis Software)
• 2022.12: Selection of NIDS mentoring support project and announcement of best practices (FDA certification of brain wave)
• 2023.01: Tofu Infrared Surveyor (Temporary Item Recognized by Ministry of Food and Drug Safety)
• 2023.02: ISO 13485:2016 Certification (Quality Management System)
• 2023.03: Isink Brain-C (Brainwave Analysis Software) FDA 510(k)
• 2023.04: KTR's software verification and cybersecurity support project
• 2023.05: Selection of KTR Smart Specialization-Based Construction Project iSyncWave2 (brainwave) developed and KC certified.
• 2023.08: MDSAP 1st audit completed.
• 2023.11: KGMP certification for head infrared irradiator completed.
• 2023.12: Selection of NIDS mentoring support project and announcement of best practices (FDA certification of brain wave analysis software)
• Guidelines for Application of Usability to the Ministry of Food and Drug Safety (Application Method for each Change Case) to be included in the guideline for civil petitioners
• 2024.01: ISO 13485:2016 (Brainwave System and Brain Wave Analysis Software) Review completed. Approval of clinical trial plan by the Ministry of Food and Drug Safety (exploration clinical trial to confirm the safety and effectiveness of infrared irradiators for patients with mild cognitive impairment of Alzheimer's disease)
• 2024.02: Support for ISO 27001 and ISO 27701 certification. (Information protection system, personal information protection certification)
• Developed strong communication and organizational skills through working on group projects.
• Worked well in a team setting, providing support and guidance.
• Self-motivated, with a strong sense of personal responsibility.
• Directed, oversaw and quality-controlled regulatory affairs for FDA and MFDS.
• Collaborated with regulatory affairs peers and produced successful worldwide regulatory assessments and submissions.
• Managed quality assurance initiatives.
• Developed and implemented quality assurance improvements.
• Designed testing scenarios for usability testing.
• Improved product reliability by conducting thorough testing procedures such as unit testing, integration testing, and stress testing.
• Improved team collaboration by establishing clear communication channels between researchers, clinicians, and support staff.
• Trained and mentored new staff to achieve efficiency and maintain daily operational consistency.
• Collaborated with colleagues to design and implement interdisciplinary projects for the academic team
• Led team of engineers in the successful completion of complex hardware development projects (ODM&OEM).
• Demonstrated strong organizational and time management skills while managing multiple projects.
• Worked flexible hours across night, weekend, and holiday shifts.
• Used strong analytical and problem-solving skills to develop effective solutions for challenging situations.
• Managed time efficiently in order to complete all tasks within deadlines.

• 2022.03: U-Healthcare ECG Recorder Change Permission (Class 3) Completed. U-Healthcare electrocardiometer
  Post-examination completed according to ISO 13485:2016. U-Healthcare electrocardiogram
• Managed and archived quality documentation and participated in internal and external quality audits.
• Directed, oversaw and quality-controlled regulatory affairs for MFDS(Korean FDA), CE and FDA.
• Spearheaded training initiatives for staff on regulatory affairs topics, promoting a culture of continuous learning.
• Actively collaborated with other departments including Quality Assurance, Regulatory Affairs, and Distribution to ensure seamless operations.

• Parental Leave for 4 kids

• Founded By the head of R&D worked with U&i
• 2019.09 ~ 2020.10.31 : CEO of Lab & People Quality Management (Quality Officer)
• 2020.02: GMP registration by bsi (ISO 13485:2016) Bioabsorbent microneedle
• 2020.05: CGMP Registration by MFDS Cosmetics Certification
• 2020.07: FDA Device List for Microneedle Patch
• Enhanced product quality by implementing comprehensive quality management systems and processes.
• Conducted internal audits for continuous improvement and ensured compliance with industry standards.
• Inspected products and worker progress throughout production.
• Streamlined document control processes, ensuring accuracy and accessibility of critical information for all team members.
• Increased efficiency of production processes by identifying areas for improvement and implementing appropriate changes.
• Applied coaching techniques and tools to support managers and team members in improving performance.
• Monitored staff organization and suggested improvements to daily functionality.

Care for family disease

• FDA Site Audit in 3 times, CE MDD with clinical evaluation by DNV.
• Regulatory Training by SGS, DNV and other testing organization.
• Understanding of regulatory affairs and requirements
• Provided professional services and support in a dynamic work environment.
• Proved successful working within tight deadlines and a fast-paced environment.
• Paid attention to detail while completing assignments.
• Cultivated interpersonal skills by building positive relationships with others.
• Resolved problems, improved operations and provided exceptional service.
• Self-motivated, with a strong sense of personal responsibility.
• Passionate about learning and committed to continual improvement.
• Proven ability to learn quickly and adapt to new situations.
• Developed positive working relationships with stakeholders to effectively coordinate work activities.
• Evaluated vendor proposals for equipment procurement, selecting optimal solutions based on performance requirements.
• Explained highly complex information in terms easily understood by non-technical personnel.
• Trained and assisted staff in validation techniques, methods and testing processes.
• Managed quality assurance initiatives.
• Developed and implemented quality assurance improvements.
• Directed, oversaw and quality-controlled regulatory affairs for FDA, CE and MFDS.
• Collaborated with regulatory affairs peers and produced successful worldwide regulatory assessments and submissions.
• Improved hardware & software quality by designing, developing, and executing comprehensive test plans and cases.
• Verified documentation to meet client requirements and vision.
• Improved team productivity by providing technical guidance and mentoring junior engineers.
• Increased operational efficiency through regular equipment maintenance, calibration, and performance monitoring.

• Registering for FDA (9 products), CE(5 products in DNV), KFDA(10 products), ANVISA(1 product), CFDA(1 product), TFDA, PMDA, COFEPRIS for Class 3 above without consulting.
• One Clinical Trial (Biodegradable Bone Screw: Class 4 in MFDS)
• Own Testing: 12 Mechanical testing, 1 chemical testing
• Third-party Testing: 2 electrical testing, 1 usability testing, 1 electromagnetic testing
• Finite element method simulation (Computer based)
• Partnered with sales, strategy and business development to identify new product opportunities, manage project portfolio and work assignments.
• Provided technical support to sales teams in addressing customer inquiries related to product specifications or applications.
• Implemented new training programs for staff, leading to higher employee retention rates and better overall performance.