Regulatory and Quality Assurance Expert

7 days ago


Subang Jaya, Selangor, Malaysia Terumo Full time
About the Role

We are seeking a highly skilled Regulatory Affairs and Quality Assurance Specialist to join our team at Terumo. The primary responsibility of this role is to maintain the registration of medical device products in Malaysia and ensure compliance with GDPMD regulations.

  • Maintain accurate records of product registrations and ensure timely submissions to regulatory authorities.
  • Develop and implement effective quality management systems.
  • Conduct regular audits to ensure compliance with GDPMD regulations and identify areas for improvement.
  • Develop and maintain SOPs for work processes within the department and inter-departmentally.
  • Participate in internal and external audits to ensure adherence to regulatory requirements.
Terumo Overview:
  • Leading medical device company.
  • Dedicated to improving healthcare outcomes.
  • Committed to regulatory compliance and quality excellence.


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