Regulatory Compliance Officer

4 days ago


Shah Alam, Selangor, Malaysia Hiredly X Full time

Hiredly X is seeking a skilled Regulatory Compliance Officer to join our team.

About the Role:

The Regulatory Compliance Officer will be responsible for assisting Regulatory Affairs in implementing and maintaining the company's quality management system according to ISO 13485 (2016) and other applicable regulatory requirements.

  • Maintain the company's ISO documentation system
  • Monitor manufacturing processes from a Quality standpoint
  • Review and sign off Device History Record (DHR) documentation
  • Monitor the quality and integrity of all products manufactured at Hiredly X

To be successful in this role, you must have a bachelor's degree in a relevant subject area, such as science or engineering. At least 4 years' work experience in the QA field is required, with experience and familiarity with ISO 13485 Quality Systems. Medical device and cleanroom familiarity is preferred. Experience with internal and external audits is also required.



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