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[담당업무] · 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
[자격요건]
· 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
- Minimum of 3-4 years of experience required in Quality Assurance
- Certifications are an advantage, including Regulatory Affairs (RAC), Quality Auditor, and NIDS RAC
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[자격요건] -경력: 경력 3~13년
-학력: 대졸
-직무기술: 품질보증
-기타: 담당업무 > 자격요건 참고
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