Regulatory Affairs Specialist
Fladger Associates
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
Vacancy posted 15 hours ago
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