Responsibilities:
-Responsible for complaint handling, Driving compliant closure and response for all complaints.
- Maintain all complaint Handling materials/records and keep records complete and accurate.
-Maintain performance of on-time reporting of MDRs/MDVs.
-Maintain product safety and compliance and report field to regulatory agency
-Assist in the development, implementation and maintenance of quality assurance programs. Ensure documents and records are kept in compliance with regulations and SOPs.
- Support Global QARA team developing new or improving existing Quality Management Systems.
- Manage on-line QMS system rolling out with the cross-function departments in APAC region and maintain the daily operation.
-Follow up RA registration plan and monitor registration schedule.
- Responsible for all Registration projects in APAC regions.
- Lead and coordinate registration material preparation for new products launching into market.
-Provide regulatory support and review on the relevant documents and reports.
-Provide technical advice on trending of data and quality systems as relates to annual reporting, management metrics and other trending, as required
Qualifications:
-Bachelor or above
-Fluent English both in writing and oral
-At Least more than 5 years’ Medical device QARA experience
-Project management experiment.
-Knowledge: A seasoned, experienced professional with a complete understanding and wide application of principle, theories, and concepts in the field
Problem solving: Develops solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires uation of identifiable factors
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The Sol-Millennium Group is dedicated to Building a Healthier Tomorrow and helping people live in a healthier world.? Our team members are committed to improve the safety and well-being of healthcare workers and their patients with the design and development of safety medical devices.????? Sol-Millennium Group is a Global Healthcare Company providing innovative products and value added services through product development, manufacturing and distribution targeting safe injections and disposal of medical devices.? Our belief that the front line professionals are critical in the development process, we continually are in touch to share knowledge, ideas with concentration on the improved functionality of injection safety which is led by our experienced Research and Development team.? The Sol-Millennium culture focuses on continuous improvement, technological innovation and customer service.

http://www.sol-m.com