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Assistant Director Regulatory Medical Device

Company Name:
Systems Technology Intl, Inc
BS degree in life sciences or engineering with at least 8 years of pharmaceutical and or medical device experience, of which at least 5 years includes hands-on medical device experience preferably with class III devices, or
Advanced degree in life sciences or engineering with at least 5 years pharmaceutical and or medical device experience, of which at least 3 years includes hands-on medical device, experience preferably with class IIII device.
Extensive knowledge of US and global regulations as it pertains to registration and maintenance of class III medical devices. Demonstrated interactions with local and global health authorities.
He/she must be able to work focused and target oriented in a complex scientific / technical environment. The incumbent will be required to focus on multiple issues at one time, and must have the ability to organize and direct diverse activities in a changing environment often under time pressure. In many cases competing objectives will have to be harmonized and prioritized to achieve overall objectives.
The ability to work within a global team framework and a multicultural environment is essential. He/she must have well developed project management skills, including interpersonal skills. Good communication skills, verbal and written, are required.
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