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Temporary RA/QA Assistant  

Bio-Rad (company)

Posted on : 20 April 2017

Project Description

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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
Position Type