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公司简介

职位概要(Job summary): The Regulatory Compliance Sr. Engineer is to monitor and ensure the compliance to external standards/requirements and Quasar Quality System Requirements in Quasar manufacturing site. 工作职责(Responsibilities): 1. Conduct routine monitoring, checking program to identify site compliance gaps and follow up gap remediation. 2. Participate in Corporate Procedure Development & Maintenance. Join Corporate audit Ｏn other sites when required. 3. Provide Regulation Compliance supporting Ｏn critical business projects, when necessary, e.g., MAH 4. Facilitate critical external audits/inspection at site. e.g., FDA inspection, NMPA audits. 5. Join cross sites QMS IT system coordination and maintenance. 6. Responsible for liaising with the company’s internal/external stakeholders to identify/understand the required Regulatory Compliance knowledge needed to provide the required expertise and advice. 7. Other tasks assigned by leader. 任职资格(Qualification) : 1. Bachelor or Master’s degree in science related field. 2. Minimum of 5 years’ experiences Ｏn Medical Device or Pharmaceutical Industry Quality Regulatory Compliance related work. Knowledgeable Ｏn international standards or Health Authorities regulations requirement. 3. Good oral and written communication skills both in English and Chinese. 4. Good interpersonal and influential skills. 5. Ability to work under pressure in a dynamic environment.

招聘职位

Sr. Regulatory Compliance Engineer 高级合规工程师

5年以上经验|本科学历

16000-20000

东莞

2026-06-12

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