Regulatory Affairs Specialist

Contract Duration: 3-6 months

Rate: Negotiable

Salary: NA $1.00

Responsibilities: Excellent employment opportunity for a Regulatory Affairs Specialist in the Jacksonville, FL area. Support ordering of export certificates (U.S. CFGs/E.U.CFS) globally for company business units & products - [60% of responsibilities]Manage external company vendors to support document authentications for regulatory submissions worldwide [20% of responsibilities]Develop operational process flow between Regulatory Operations team and stakeholders to streamline coordination of regulatory submission requests for company medical device products Represent Regulatory Operations group at stakeholder team meetings to provide status update on documentation handles by the group Maintain current knowledge of US and International Regulations; guidance and standards within the scope of Regulatory Operations for medical devices and provide strategic input to teams to develop regulatory submission timelines [15% of responsibilities]Analyze FDA Unified Registration and Listings (FURLS) account related activities of various company business units in support of projects [5% of responsibilities]

Experience: Bachelor's Degree is required 3-5 years of related experience