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Temporary RA/QA Assistant  

Posted on : 20 April 2017

Project Description

Tracking Code SGP070 Job Description Manage and prepare documents for new, renewal and change regulatory submission in Singapore and Malaysia Ensure timely communication with internal and external customers relating to product submission, renewal and change progress Monitor and communicate changes in IVD medical device law and regulations in a timely manner Handle Global Product quality notification/ FSN, communicate and perform FSCA/ Adverse event reporting with local authority Prepare and support audit for re-certification/ surveillance of ISO9001  and GDPMDS, and external audits with 3PL and/or customers Maintain local Quality management system in compliance with Global standards, and meeting ISO9001 and GDPMDS requirements Required Skills Able to work independently Meticulous Good communication skills in English and interpersonal skills. Required Experience Diploma/ Degree in Lifesciences or Biomedical At least 1 year of experience in Regulatory Affairs is preferred Job Location Singapore, Central Singapore, Singapore Department SEA G&A RA QA(SEABRNR) Position Type Temporary

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