[About 지멘스 헬시니어스]

지멘스 헬시니어스는 전 세계 70개국 이상의 국가에서 약 7만명의 임직원이 의료산업에 최첨단 기술을 제공하는 기업으로서 영상 의학, 실험 진단 사업, 의료 IT 부문에서 최신 기술을 선도하고 있습니다.

지멘스 헬시니어스 한국 지사에서는 약 1,100여명 이상의 임직원이 영상 및 진단의료기기 세일즈, 서비스, 연구개발, 생산 등의 업무를 담당하고 있습니다. 서울, 부산, 대구, 대전, 전주, 광주 등 국내 주요 도시에서 세일즈, 서비스 오피스가 운영되고 있으며, 초음파기기 연구개발 및 생산은 분당 및 포항에서 이루어지고 있습니다.

지멘스 헬시니어스는 미국 GPTW 연구소(Great Place to Work Institute)가 주관하는 ‘2024년 일하기 좋은 기업‘에 선정되었습니다. 자율적이고 유연한 근무 환경을 제공하고 업무와 삶의 균형을 맞추기 위한 다양한 제도를 마련하여, 지속 가능한 헬스케어 시장의 리더로 자리매김하고 업계의 본보기가 되고자 노력하고 있습니다.

The QT department manages import medical device licensing, post-market surveillance, and Quality Management System (QMS) operations to ensure that products are supplied to the domestic market safely and in compliance with regulations. It serves as a bridge between regulatory authorities, headquarters, and internal departments, playing a critical role in guaranteeing the company’s quality and reliability.

Regulatory Affairs: Handles new and modified import medical device registrations and notifications, monitors regulations, responds to regulatory authorities, and manages compliance of labels, instructions for use, and advertising materials.

Post-Market Surveillance: Oversees distribution management in accordance with importer obligations and reports adverse events related to medical devices.

Quality Management System (QMS): Establishes and revises SOPs/WIs, conducts internal training on quality documentation, responds to internal and external audits, and maintains and continuously improves the quality system.

[담당 업무]

• You will be in charge of medical device licensing and modifications in accordance with the Medical Device Act and related regulations.
• You will manage GMP (Good Manufacturing Practice) activities in compliance with the Medical Device Act and related regulations.
• You will monitor and implement relevant domestic and international regulations.

• You hold a bachelor’s degree or higher in a relevant field (e.g., Biosciences, Chemistry, Engineering).
• You demonstrate proficiency in MS Office and Hancom Office.
• You have excellent translation and language skills (fluent in English speaking and writing).
• You have experience in medical device licensing, post-market surveillance, and GMP activities in accordance with the Medical Device Act.
• You have minimum of 2 years of experience in related work (medical device licensing, post-market surveillance, and GMP activities in accordance with the Medical Device Act).