Regulatory Affairs Specialist

Jacksonville, FL


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]

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