Seungyeon (Vivian) Lee

[Regulatory Compliance]

• Developed and implemented innovative product registration strategies to achieve business goals and stay competitive
• Established and submitted regulatory applications to the local health authority
• Completed the KGMP renewal on time successfully
• Collaborated with internal and external stakeholders to achieve the business plan by providing the regulatory-related issues associated with compliance
• Mentored and coached team members on RA / QA topics, strategies, and individual performance development plan
• Led and participated the global projects with regard to the RA process
• Established and maintained relationships with the local and ASPAC industry groups and works with industry peers to respond accordingly to the competent Authorities in matters of regulatory issues and to influence local policies.
• Planned and budgeted accurately to provide business with resources needed to operate smoothly

[ Quality Compliance]

• Created and achieved product quality objectives and met product specifications.
• Cross-trained existing employees to maximize team agility and performance.
• Developed and maintained relationships with customers and suppliers through an annual audit

[Regulatory Compliance]

• Registered medical devices mainly the neurovascular implant including medical equipment
• Communicated and aligned with line manager, business lead, and other stakeholders on the registration plan and strategy, and timely update on the status as well as the actions taken to address any delay or potential delay
• Conducted KGMP submission and on-site audit at foreign manufacturer site for new certificate and periodical renewal
• Maintained the licenses and periodical re-evaluation to reflect the latest description
• Communicated well with global RA and R&D team for the documentation required and support needed
• Reviewed the documents received, prepare local dossiers, and submit to local health authorities
• Communicated with health authority for inquiries regarding the registration
• Reviewed and evaluated the regulatory Changes/Trends, lead the actions to address the changes, and minimization the business impact

[Quality Compliance]

• Maintained and improved the Quality Management System (QMS)
• Led the internal audit and external audit, including the audit/inspection by the regulatory authority, and notify body
• Managed and controlled the quality KPI
• Managed and created the process for the UDI registration with corporate UDI and internal TFT
• Provided Quality training to business stakeholders

[Reimbursement]

• Managed overall medical reimbursement registration process and pricing and code maintenance in line with government requirements and company strategy
• Submitted dossier to HIRA and closely follow up with authorities after the submission
• Managed pre/intra/post-registration works for precise and efficient document control and data management
• Secured the current reimbursement price and expand the reimbursement guideline to the related product portfolio
• Supported the nHTA(New Health Technology Assessment) process , medical service, and indication guideline

• Registered medical devices as mainly neurosurgery and orthopedic devices including medical equipment
• Managed licenses and created a local labels to meet the regulation
• KGMP submission for a new certificate and periodical renewals
• Maintained the licenses and periodical re-evaluation to reflect the latest description
• Developed skills in relationships with government reviewers and understanding of processes for approval products

• Managed and implemented the medical device registration, IRB approval for clinical trials
• Implemented the market research and prior art search for new business and research
• Assisted in the planning of the marketing strategy to develop medical devices and medical drugs

• Implemented submission to the approval of a medical drug and IND
• Registered the In Vitro Diagnostic Reagents as class 4
• Managed and conducted the DMF Annual Report Application
• Provided knowledge and approval strategy transfers to clients

• KFDA approval of medical devices and cell therapy and work for the RA
• Responsible for product quality control testing and contributed to creating secure products