Overview
Work History
Education
Skills
Certification
Military Service
Overseas Experience
Confirmation
Software
Timeline
Hi, I’m

Steve, 장지건

Medical Device Regulatory Affairs Manager
구리시,41
Steve, 장지건

Overview

12
years of professional experience
2
years of post-secondary education
2
Certifications
2
Languages

Work History

P.U.M.P

Technician
10.2024 - 03.2025

Job overview

  • Electric Scooter/Bike Maintenance & Repair
    Parts Replacement & Inspection
    Inventory Management (Incoming/Outgoing)
    Material Management
    Daily Status Reporting

Stentech

Manger
01.2024 - 02.2024

Job overview

  • Key Responsibilities:

    Overall planning for the production process of cardiac stent medical devices
    Operation of the quality management system
    Inventory and logistics management
    Skills and Knowledge:

    Knowledge of relevant laws and regulations (ISO 13485, GMP, etc.)

TIUL

Technician
08.2023 - 12.2023

Job overview

Stage LED Event Equipment Rental (Installation, Operation, Management, and Collection): Experienced in the full lifecycle of stage LED event equipment rentals, including:

Installation: Proficiently installing and configuring stage LED displays and related equipment according to event specifications and safety regulations.
Operation Management: Skilled in operating and managing stage LED systems during events, ensuring optimal performance and addressing any technical issues that may arise.
Management: Responsible for the proper care, maintenance, and inventory management of stage LED equipment.
Collection: Efficiently dismantling and collecting equipment after events, ensuring all items are accounted for and returned in good condition.


Transportation: Safely and efficiently transported stage LED equipment and other event materials to and from event venues

ARIVA

Manager Director
04.2023 - 06.2023

Job overview


  • Audio System Management and Construction Managemen
  • Video System Management and Construction Management
  • Document Management

CJ Logistics.

Logistics Manager
07.2020 - 09.2020

Job overview

  • Managed logistics budgets and forecasting to achieve cost-effective operations.
  • Developed strong relationships with vendors, leading to improved pricing and service levels.
  • Improved on-time delivery rates by optimizing transportation routes and scheduling.
  • Negotiated transportation and logistics contracts to reduce shipping costs.

DSHITECH

Manager
04.2019 - 05.2020

Job overview

1) Medical Device Regulatory Affairs (Class I, Class II, Combination Medical Devices): Including FDA approval

ex) VBM GMP_Y 2020 , TT 15/20 document


2) reimbursement submissions to (HIRA) in Korea.

ex) Accredited in non-covered services insurance TECNO

3) Correspondent (KORES) Tasks: Contacting manufacturers regarding requests and new vendor emails - Obtaining manufacturer documentation.
4) Preparing for Importer GMP (Good Manufacturing Practice) Certification - Cardiovascular Implants and Devices.
International Trade and Purchasing.
5) Quality Control (QC) and Quality Assurance (QA) (Manufacturing and Import).
6) Quality System Management.
7) Overall Management Tasks.
8) Delivery



Manger

Estem Medical
02.2018 - 04.2019

Job overview

1. Import Regulatory Affairs (QA/RA) for German Medical Device (Heart Rate Monitor)
* Handling import regulatory affairs (Quality Assurance & Regulatory Affairs) related to German medical devices, specifically heart rate monitors.
2. Pamphlet Creation and Management:
* Creating and managing product pamphlets.
3. Trade Document Management and Risk Management:
* Managing trade-related documents and addressing risk management issues.
4. Communication & Documentation with Manufacturers (KORES):**
* Managing communication and documentation with manufacturers (KORES).
5. Quality Control & Quality Assurance (QC & QA):
* Performing Quality Control and Quality Assurance tasks.
6. Inventory Management and Sales Support:
* Managing inventory and providing sales support.

Executive Chauffeur

IBK
02.2016 - 02.2018

Job overview

1. Supporting Meetings with the Head of Corporate Bank and the Head of Institutional Client Department:
2. Performing Tasks / Executing Duties

Researcher

한국화학융합시험연구원(KTR)
06.2015 - 12.2015

Job overview

Overseas Certification Technical Support (US, Europe):

1) Provide technical support to companies seeking overseas certification, leveraging expert knowledge of US (e.g., UL, FCC) and European (e.g., CE, RoHS) certification standards

2) Systematically manage various data generated at the 1381 Certification Center, including test data, certification data, and

3) Perform general affairs necessary for the operation of the 1381 Certification Center, supporting the efficient operation of the center. Assist in the smooth operation of the center through activities
Risk Management within the 1381 Certification Center:

4) Identify and evaluate potential risk factors within the 1381 Certification Center, and establish and implement risk management plans.

GMP 심사원

의료기기 국제 적합성평가_국제 심사원(부자격소유)
03.2015 - 06.2015

Job overview

  • ISO 9001 심사원(보): ISO 9001 Auditor (Trainee) / ISO 9001 Provisional Auditor
    ISO 14001 심사원(보): ISO 14001 Auditor (Trainee) / ISO 14001 Provisional Auditor
    내부심사원 자격 (시험/교정 분야): Internal Auditor Qualification (Testing/Calibration field)
    ISO 17025 운영실무 (시험/교정 분야): Practical experience in ISO 17025 operation (Testing/Calibration field)
    공업 통계학: Industrial Statistics
    해외 인증 (절차, 시스템, 관련 지식): Overseas Certification (Procedures, Systems, and Related Knowledge)
    환경 규제 ( HSPM <유해물질 관리법>, ROHS 1,2): Environmental Regulations (HSPM <Hazardous Substance Management Law>, RoHS 1 & 2)
    통합 경영 시스템: Integrated Management System (IMS)

Sourcing Specialist

RS_AUTOMATION
03.2013 - 01.2015

Job overview

Responsibilities:

1) Foreign Procurement (Overseas Purchasing): Product sourcing, delivery management, and order placement.
2) Domestic Material Distributor Management: Product sourcing, delivery management, and order placement.

Key Tasks:

Procurement Operations:


1) Identifying material and product shortages in ERP based on unmet production plans and taking appropriate action.
Data Management (Scope: All Purchased Materials Data for In-House Production):
2) Managing and reporting on outstanding materials, products, and inbound/outbound transaction details.
Supplier Payment Processing:
3) Generating monthly transaction statements and processing tax invoices.
4) ICR (Inter-Company Reconciliation) Operations:
Issuing and processing debit/credit memos on specific materials at the end of each month to reduce material costs.
Reducing costs through exchange rate fluctuation gains.

Education

MEDICI

빅데이터 분석 전문가 양성과정 from 파이썬, HTML, SQL 데이터 분석, 웹크롤링계발, Django, 머신러닝, 딥러닝
03.2022 - 10.2022

University Overview

  • 3개의 프로젝트 수행
  • 파이썬을 이용한 데이터 전처리 및 시각화
  • 머신러닝을 이용한 전처리 및 모델링
  • 머신러닝 및 딥러닝 이용한 전처리 및 모델링 웹프로젝트

멀티 캠퍼스

데이터분석 from 파이썬, HTML, SQL 데이터 분석, 웹크롤링계발, Django, 머신러닝, 딥러닝
06.2021 - 11.2021

University Overview

  • 3개의 프로젝트 수행
  • 파이썬을 이용한 데이터 전처리 및 시각화
  • 머신러닝을 이용한 전처리 및 모델링
  • 머신러닝 및 딥러닝 이용한 전처리 및 모델링 웹프로젝트

오산고등학교
03.2000 - 12.2000

Skills

종보통운전면허

Certification

운전면허 1종

Military Service

군필, 10/01/02 ~ 11/30/04, 육군, 병장

Overseas Experience

미국, 2년 3개월, 12/01/06, 02/28/09, 커뮤니티 컬리지 1학년 수업 및 어학연수 및 아르바이트 경험

Confirmation

위의 모든 기재사항은 사실과 다름없음을 확인합니다.

Software

파이썬

웹크롤링

디자인

Timeline

Technician

P.U.M.P
10.2024 - 03.2025

Manger

Stentech
01.2024 - 02.2024

Technician

TIUL
08.2023 - 12.2023

Manager Director

ARIVA
04.2023 - 06.2023

MEDICI

빅데이터 분석 전문가 양성과정 from 파이썬, HTML, SQL 데이터 분석, 웹크롤링계발, Django, 머신러닝, 딥러닝
03.2022 - 10.2022

멀티 캠퍼스

데이터분석 from 파이썬, HTML, SQL 데이터 분석, 웹크롤링계발, Django, 머신러닝, 딥러닝
06.2021 - 11.2021

Logistics Manager

CJ Logistics.
07.2020 - 09.2020

Manager

DSHITECH
04.2019 - 05.2020

Estem Medical

Manger
02.2018 - 04.2019

IBK

Executive Chauffeur
02.2016 - 02.2018

한국화학융합시험연구원(KTR)

Researcher
06.2015 - 12.2015

ISO 심사원(부) 외 5종

06-2015

의료기기 국제 적합성평가_국제 심사원(부자격소유)

GMP 심사원
03.2015 - 06.2015

RS_AUTOMATION

Sourcing Specialist
03.2013 - 01.2015

운전면허 1종

02-2001

오산고등학교
03.2000 - 12.2000
Steve, 장지건Medical Device Regulatory Affairs Manager