KEY RESPONSIBILITIES & ROLE

• Registration of New Products 
  • Request to and search Registration Dossier for the required products
  • Review the information and documents from ConMed and related manufacturers.
  • Prepare the technical documents and compile applications.
  • Prepare the applications and arrangement related to product registration such as testing, sample preparation, etc.
  • Communicate with MFDS and related authorities and organization in process of product registration.
  • Follow up any additional and/or supplementary requests to complete product registration.
  • After completion of product registration, process post-registration activities defined by company.
• KGMP Certification
  • Process KGMP certificates for new facilities and/or new product category through dossier or on-site inspection
  • Process periodic renewal of KGMP certificates through dossier or on-site inspection
  • Request and search the documents required.
  • Review the information and documents from ConMed and related manufacturers.
  • Prepare the submission dossiers for KGMP certification.
  • Prepare the applications and arrangement related to KGMP certification including on-site inspections.
  • Take a role of translator for English-Korean in on-site inspections
  • Communicate with MFDS and related authorities and organization in process of KGMP certification.
  • Follow up any additional and/or supplementary requests to complete KGMP certification.
  • After completion of KGMP certification, process post activities defined by company.
• Change control and Maintenance of existing Licenses including License Renewals
  • Review and make reply on the change notices and impact assessment to be assigned in timely manner.
  • Process license renewal projects to be assigned.
  • Gap analysis of existing licenses and identifying necessity of license and/or KGMP updates according to related changes and Korea regulations
  • Request and search the documents required for the projects.
  • Review the information and documents from ConMed and related manufacturers.
  • Prepare the submission dossiers for the projects.
  • Prepare the applications and arrangement related to the projects.
  • Communicate with MFDS and related authorities and organization related to the projects.
  • Follow up any additional and/or supplementary requests to complete the projects.
  • After completion of projects, process post activities defined by company.

• Quality Management and Post-registration activities
  • Update registration index and database including maintenance activities.
  • Prepare Korean device master file and product labelling in Korean language including maintenance activities.
  • Supporting RA/QA dept head in establishing and revising the QMS and related SOPs, Forms and quality documents
  • Supporting RA/QA dept head for ISO 13485 certification and maintenance
  • Personnel training on quality system
• Regulatory Compliance 
  • Monitor and understand on Korean regulations related to medical devices as well as related international standards and regulations.
  • Process any post-registration and regulatory compliance activities when assigned such as complaints handling, product recalls and FSCA, safety information reporting to MFDS, etc.
  • UDI database registration and maintenance
• Market Access affairs
  • Reimbursement registration
  • Reimbursement code maintenance
  • Monitor regulations on reimbursement and attend various meetings on reimbursement
• Others
  • Update through self-study and training related to RA/QA tasks.

REQUIREMENTS & QUALIFICATIONS

1. Bachelor’s degree in engineering, science and healthcare (Medical engineering major preferred)
2. Related experience required (1~2 years preferred)
3. Skill: Interpersonal communication, Organization, Negotiation
4. Language Skills:  English 
5. Good computer skill is a plus (Microsoft Office, Oracle, Internet etc)
6. Knowledge on Anatomy, Chemical/Physical properties is a plus.