Senior Regulatory Affairs Specialist, Medical Devices

Senior Regulatory Affairs Specialist, Medical device
- A leading US healthcare MNC 
- Regulatory Affairs responsibility for Singapore and selected regional countries


Our client is a leading healthcare MNC with a global business in medical devices and consumables.
An exciting opportunity exists as a Regulatory Affairs Specialist responsible for medical device registration for Singapore and 1 or 2 other selected countries. The incumbent would be a key member of the regional regulatory team and reporting into the RA Manager. He/she will also be involved in product listing, delisting, reporting of adverse events, review change control requests, labelling change requests and submit all activities with authorities and the regional team’s requirements. 
To qualify you would have a relevant degree in life science or in a related biomedical subject and will have a minimum of 2 years of experience in regulatory affairs. Experience in regulatory affairs within the medical device industry is preferred. You would have excellent understanding of the regulatory framework for medical devices in the region and an understanding of quality systems regulations, recalls and correction and labelling requirements. You would have strong oral and written communication skills.

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