Bachelor’s degree in
Science, Lifescience, Engineering with minimum 6 years of regulatory,
reimbursement, quality management system and quality experience in medical
device company.
Knowledge in ASEAN Medical
Device Directive, US FDA medical device regulation or EU Medical Device
Regulation would be advantageous.Must have good knowledge and
understanding of Technical Files and product registration process.Familiar with design and
development, manufacturing testing in order to understand the technical
reports for product registration submission.Familiar with standard
related to Quality Management Systems (ISO 13485) with internal auditor
certification.Mandatory to have strong
written and oral communication in English and Korean.Good Technical report
writing skills.Strong interpersonal skills,
written, oral communication and able to work in cross-functional team,
familiar with MNC and start-up environments.
