We currently have a great opportunity available for a Regulatory Affairs Director. The Director position in Regulatory Affairs is focused on developing the regulatory strategy for new and modified Sysmex medical device products. The individual will need to identify, assess and communicate regulatory development, submission strategies, and interface with relevant regulatory authorities. The Director will be the regulatory subject matter expert on medical devices and In-Vitro Diagnostics. The position will be responsible for directing the activities of the Regulatory Affairs department, including hiring and mentoring Regulatory Affairs Associates and ensuring accurate and timely product submissions for Sysmex.
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