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Sue Werner

Senior Director of Regulatory and Quality @ Saladax Biomedical Inc.

Sue Werner Contact Details

Location:
Rochester, New York Area
Work:
Senior Director of Regulatory and Quality @ Saladax Biomedical Inc.
Regulatory Affairs Manager @ Ortho Clinical Diagnostics
Research Scientist @ Eastman Kodak
Education:
About:

Specialties:IVD's PMA's

Regulatory Affairs Manager @ Submission of multiple PMA's and support for pre-approval and BIMO inspections and all post-approval maintenance activities such as Annual Reports, 30 Day Notices, PMA Supplements. Experience with worldwide licensing activities. Knowledge of CLIA Waiver applications. Involvement in trade association activities. From November 1997 to Present (17 years 10 months) Research Scientist @ 

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