Quality Assurance & Regulatory Affairs Engineer

Quality Assurance & Regulatory Affairs Engineer

  • Location

    Singapore, Singapore

  • Sector:

    Life Sciences

  • Job type:


  • Salary:

    S$5000 - S$6500 per month

  • Contact:

    Kareen Wong

  • Contact email:


  • Job ref:


  • Published:

    4 months ago

  • Expiry date:


I am collaborating with an interesting medical devices start-up, focusing on a very niche area of therapy. They are looking for RA/QA engineer to embark on a challenging and meaningful journey with them. You will be working closely alongside process-owners and responsible for maintenance of quality systems.

What are the main responsibilities?

  • Maintenance of QMS according to international ISO standards, establishing documentation control system and ensuring project milestones and reports to various stakeholders are met in a timely manner.
  • Lead internal and supplier audits to ensure compliance to company's and international quality standards
  • Compilation of technical dossiers and DHFs, regulatory submissions for CE-marking and target markets

What I am looking out for in yourself:

  • Degree in science, engineering or related fields
  • At least 5 years of experience in quality assurance, specifically in establishment and maintenance of QMS.
  • Strong knowledge in ISO 13485 is required and working exposure with medical device software will be an added advantage
  • Highly driven and ambitious personality with strong communication skills to liaise with both internal and external stakeholders.

Please send your resume in WORD format by clicking the apply button below or contact Kareen Wong on +65 6701 1518 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1878552 (Wong Yin Ling, Kareen).