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Sr Regulatory Affairs Specialist
This Sr Regulatory Affairs Specialist is responsible for researching scientific and regulatory information for review and preparation of regulatory submissions intended for the FDA and Health Canada. This position will work with the FDA and Health Canada to ensure approval/clearance/license of products. In addition, this person is responsible for review of promotional material and labeling for compliance with FDA and Health Canada regulations and overseeing annual establishment registrations and device listings. This position works under minimal supervision and reports to the Director, Regulatory Affairs and Quality for Straumann North America. This position is responsible for, but not limited to, the following: Generate and review regulatory submissions
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