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Regulatory Affairs Administrator

  • Full Time, onsite
  • Transmedic Healthcare Sdn Bhd
  • Kuala Lumpur Pharmaceuticals & Medical Devices (Healthcare & Medical) Full time Add expected salary to your profile for insights, Malaysia
Salary undisclosed

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Responsibilities:

  • Prepare supporting documents for Medical Device submissions to local health authority and follow through to approval.
  • Responsible for regulatory and product licensing-related activities, especially relating to medical devices.
  • To update approval database and other tracking tools.
  • Track registration validity.
  • Support the management of document control process for Quality Management Systems in compliance with GDPMD and any other standards as appropriate.
  • Support development and maintenance of standard operating procedures and working practices.
  • Support (internal & external) audits to ensure that regulatory and quality requirements have been met.
  • Conduct all assigned work in compliance with organization’s safety and quality.
  • Any other responsibilities as required and instructed by supervisor and the management.

Requirements:

  • Minimum Diploma holder, preferably in Biomedical Sciences/Engineering, Biology, Biochemistry or Science related background.
  • Having at least one-year regulatory experience in Medical Devices will be an advantage.
  • Fluent English; excellent written and spoken skills.
  • Proficient in Microsoft Office.
  • Good interpersonal skills.
  • Able to multi-task.
  • Meticulous.
  • Takes initiative.
  • Able to work independently, but also a good team player.
  • Fully vaccinated with covid-19.