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.