Clorissa Hawkins

Experience

1. Principal International Regulatory Affairs Specialist

   Immucor, Inc

   Apr 2015 — Present · Norcross, GE

   Hired to build a Global Regulatory Department that enhanced the go-to-market competitiveness. • Hired and trained under a top China Regulatory Professional • Effectively and promptly developed relationships with the Immucor Sales team and the Distributors. • Managed and coordinated the regulatory licenses of product lines manufactured in the EU, Canada and US. • Managed and coordinated license variations and renewals in over 80 Countries and Territories. • Developed registration tracking system with controls to avoid shipping to Countries that were not licensed to market. • Established team building and communication with all five, transfusion and transplant, manufacturing sites. In turn, developed communication between the Regulatory departments, the Immucor Sales team and the Distributor. Often acted as the lead representative for all sites. • International regulatory lead in new Instrument product teams from the development stage to the successful market launch. • Learned the complexities of China medical device registrations. Submitted for several products and was successful in registrations and renewals. Worked with the Clinical Team to help with the difficult requirements for testing. • Learned and still learning the complexities of the new EU IVDR 2017/746 impact on rule-based classification system, requirements for clinical evidence and post market performance.

Education

• University of North Georgia

  BS, Chemistry, Math

  1993 — 1997