Principal Duties and Responsibilities

• New product registration, Line-extension registration
• Amendment of licenses, License renewal
• Communicate and align with the global regulatory team to get support for local product registration and manage local regulatory systems and processes.
• Documentation update for registration information (Update for; Registration master file, Sharepoint master file, Distribution registration folder, etc.)
• Provide product registration status and results to the business team and related parties to help their plan and preparation in advance, work collaboratively with the business team, and identify and seek resolution of registration and quality issues for the operational effectiveness

• KGMP maintenance e.g. on-site audit and document audit
• Preparation of Korean labeling documents; Korean IFU & Korean label
• Prepare/revise/control QM, PD, and SOP to ensure compliance with the Corporate and the MFDS requirements for Korean operation
• Track and follow up on the new regulation/requirement (e.g. GMP, GSP, MDA, etc.)

Expected Areas of Competence

• Competent English language skills (reading, writing, listening, and fluent speaking)
• Comprehensive knowledge of MFDS regulations
• Strong writing and communication skills; ability to communicate effectively at multiple levels including with regulatory authorities
• Knowledge of medical device products (Implants and/or electronic devices) and regulations and ability to interpret them
• Ability to manage multiple projects
• Responsible, professional, detail-oriented
• Strong computer skills

Education/Experience Requirements

• Bachelor’s Degree in life sciences, technical (engineering), or related field; advanced degree strongly preferred
• 1~7 years of experience required in Regulatory Affairs and/or Quality
• Certifications an advantage including Regulatory Affairs (RAC), Quality Auditor, and NIDS RAC

Travel Requirements