< Job Function >

Regulatory Affairs/Quality/Reimbursement

< Job Summary >
- New product registration & Maintenance of existing product licenses
- Compliance with MFDS & Corporate QA requirements
- Market Access

< Principal Duties and Responsibilities >
* New product registration & Maintenance of existing product licenses
- New product registration, Line-extension registration
- Amendment of licenses
- Communicate and align with global regulatory team to get support for local product registration and manage local regulatory system 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 business team and related parties to help their plan and preparation in advance, and work collaboratively with business team, and identify and seek resolution of registration and quality issue for the operational effectiveness

* Compliance with MFDS & Corporate QA requirement
- 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 Korea operation
- Track and follow up the new regulation/requirement (e.g. GMP, GSP, MDA etc.)

* Market Access
- Reimbursement price listing for New product (value evaluation)

< Expected Areas of Competence (i.e. KSAs) > 
- Competent English language skills (reading, writing, listening, and speaking)
- Comprehensive knowledge of MFDS regulations and pricing guidelines of HIRA
- Strong writing and communication skills; ability to communicate effectively at multiple levels including with regulatory authorities
- Knowledge of medical device products 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
- Minimum of 3 years of experience required in a Regulatory Affairs, Quality and/or Market Access
- Certifications an advantage including Regulatory Affairs (RAC), Quality Auditor, and NIDS RAC

< Travel Requirements >
- No reason for disqualification for oversea travels