< Principal Duties and Responsibilities > 

* Management of quality system 

- Management of quality documentation (Quality Manual, Procedures, PMF, Local Language Label, etc)
- ISO 13485/MFDS/Corporate audit 
- CAPA & Risk management
- Supplier management
- Quality release of repaired products

* Post-market surveillance activities

- Complaint handling and follow-up in Korea
- Assess the reportability of global complaints and report foreign adverse events to MFDS
- Field action including recall activity, quality hold, issue evaluation, etc
- PMS data collection for license renewal and reevaluation 

* Compliance with MFDS requirements
- Maintenance of KGMP certificates, including on-site audits and document audits
- UDI registration and maintenance and Monthly supply report
- Track and follow up on the new regulations/requirements 

< Expected Areas of Competence (i.e. KSAs) >  

- 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
- Minimum of 4-5 years of experience required in Quality Assurance
- Certifications an advantage including Regulatory Affairs (RAC), Quality Auditor, and NIDS RAC

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