[의료기기/품질관리] Senior Quality Analyst
공고 저장
연봉 ₩50,000,000 - ₩80,000,000 per annum
근무지역 Seoul Capital Area
FULL_TIME컨설턴트 Gulshoda Omontosheva
잡레퍼런스 1830310/001
채용 공고일 2023년 2월 14일 (화)
seoul healthcare/quality-assurance 2023-02-14 2023-04-15 manufacturing-and-production 서울시 Seoul Capital Area KR KRW 50000000 80000000 80000000 YEAR Robert Walters https://www.robertwalters.co.kr https://www.robertwalters.co.kr/content/dam/robert-walters/global/images/logos/web-logos/square-logo.png true
A global biotechnology organisation is searching for a Senior Quality Analyst. The successful candidate will be accountable for ensuring adherence to medical device acts, and other regulations. This position is based in Seoul.
Responsibilities:
- Organise inspection of international manufacturers
- Oversee 3PL warehouse operations processes
- Support adherence to regulations in line with marketing, sales, FSE, and authorities
- Track local regulatory changes, analyse, and inform key organisations of the results
- Handle onboarding and monitoring of channel partners by performing review, audit, and documentation
- Acquire accurate information, such as product returns, complaints, adverse events, etc.
Requirements:
- Bachelor’s degree or above (biologics, chemical, or other science major is ideal)
- More than 7 years of experience in quality assurance or regulatory affairs
- Knowledge of medical devices, IVD regulations, and ISO 13485
- Strong interpersonal skills
- Ability to work with teams
- Proficient in written and verbal English
About the Company:
A worldwide biotechnology firm that provides high-quality solutions. This company specialises in cutting-edge research that has aided in the growth of various scientific domains.
1830310/001
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