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Responsibilities: • Maintains the database for tracking change requests. • Reviews, analyzes and evaluates post approval manufacturing changes for contact lens products and determine the appropriate regulatory pathway. • Prepare internal documentation in support of 510(k) and PMA products. • Assist with the technical preparation of PMA Supplements and FDA Annual Reports. • May provide regulatory support for business critical projects. Qualification: • Bachelors Degree - Scientific Discipline ...

Start Date: April 15 - December 31, 2013 Position Location: All of Florida, including Jacksonville, Miami, Pensacola, Tallahassee, Orlando, Fort Walton, Panama City, Gainesville, Sanford, Lake City, Jacksonville, West Palm, Brooksville, Spring Hill, Clermont, Middleburg, St. Augustine, Daytona Beach, Altemonte Springs, Clearwater, Holiday, Largo, St. Petersburg, Bartow, Winterhaven, Lakeland, Sarasota, Cape Coral, Naples, Fort Myers, Kissimmee, Melbourne, Fort Pierce, Coral Springs, Fort Lauderdale, ...

Clinical Trials Project Manager Consulting Project Jacksonville, FL [email removed] | 646.790.8355 Description: Manages the study preparation, conduct, and close out of clinical trials. May provide support on product approval applications. • Compiles information required for the clinical trial project quality plan including project timelines, resourcing, budget management and reconciliation, contract negotiation and finalization, and review and management of scopes of work and change orders. • ...

Regulatory Affairs Analyst Consulting Project Jacksonville, FL [email removed] | 646.790.8355 I am heading up a search for a Regulatory Affairs Analyst in Jacksonville, FL. This is a long-term contract position. Please review the details and let's discuss Title: Regulatory Affairs II Description: Description: 1. Maintains the database for tracking change requests. Reviews, analyzes and evaluates post approval manufacturing changes for contact lens products and determine the appropriate regulatory ...