Regulatory Affairs Manager (Medical Device) Job in Texas (TX), Research and Development Career, Full Time Jobs in Novartis Pharmaceuticals
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Regulatory Affairs Manager (Medical Device) job in Fort Worth

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Novartis Pharmaceuticals jobs
Texas (TX), Fort Worth
Job Code:  248308BR
Employer:  Novartis Pharmaceuticals
Category:  Research and Development
Job Type:  Full Time

Location
Country:  United States
State:  Texas (TX)
City:  Fort Worth
Map: 
09/05/2018

Description
The Regulatory Affairs Manager is responsible for the development and implementation of the regulatory strategy (as applied to project, process, and/or product), working independently.

MAJOR ACCOUNTABILITES

• Manages the U.S. FDA Class II and Class III medical device submissions.
• Responsible for EU Medical Device Directive 93/42/EEC and Class I, IIa, and IIb medical devices.
• Supports medical device registrations in Rest of World.
• Supports all the regulatory aspects of the product lifecycle.
• Leads close collaboration with internal stakeholders and supports multiple projects.
• Identifies and executes non-project related \• Bachelor's Degree or equivalent years of directly related experience (high school +13 yrs; Assoc.+9 yrs; M.S.+2 yrs; PhD+0 yrs)
• The ability to fluently read, write, understand and communicate in English
• 5 Years of relevant and related work experience
ref: (248308BR)
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