2012 -2014 Regulatory Affairs Specialist @ Synovis Life Technologies/ Baxter Healthcare International
2009 -2012 Senior Regulatory Affairs Associate @
2008 -2009 Regulatory @ MFG Solutions
2005 -2007 Regulatory @
2005 -2007 Environmental @
Melissa Frank Education
University of Minnesota Duluth 1997-2005
Melissa Frank Skills
Regulatory Affairs
FDA
Medical Devices
ISO 13485
Validation
Quality System
GMP
Biotechnology
CAPA
Chemistry
Cross-functional Team Leadership
ISO 14971
Microbiology
Product Development
Product Launch
R&D
Regulatory Requirements
Regulatory Submissions
Design Control
Regulatory Compliance
Regulatory Documentation
Risk Assessment
Risk Management
Auditing
Melissa Frank Summary
Melissa Frank, based in Red Lodge, MT, US, is currently a Independent Consultant, Technical File Reviewer at Castle Mountain Regulatory and Quality LLC.. Melissa Frank brings experience from previous roles at DEKRA, BSI, Abbott and Synovis Life Technologies/ Baxter Healthcare International. Melissa Frank holds a 1997 - 2005 University of Minnesota Duluth. With a robust skill set that includes Regulatory Affairs, FDA, Medical Devices, ISO 13485, Validation and more. Melissa Frank has 3 emails and 2 mobile phone numbers on RocketReach.
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