Regulatory Affairs Manager (Medical Device) job in Fort Worth
|Employer:|| Novartis Pharmaceuticals|
|Category:||Research and Development|
|Job Type:||Full Time|
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.|
• 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
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