Assistant Director, Regulatory Medical Device

Location :
Whippany, NJ
Assistant Director, Regulatory Medical Device
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
o 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.
o 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.
o 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.
o 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.
o As necessary, the Incumbent may called upon to assume specific leadership roles and direct subordinates on specific work-related projects.
o A clear understanding of cultural and business needs while working in a global project team environment.

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