RA and QA Director and In-house Counsel @ (August 2004 - January 2019)
Sr. Regulatory Affairs Specialist @ (November 2000 - August 2001)
RA and QA Manager @ Prucka Engineering, Inc. / GE Medical Systems (December 1997 - November 2000)
multiple positions held @ Surgimedics, Inc. (June 1992 - December 1997)
J. McDonald Education
Suffolk University Law School
Juris Doctor (Certificate of Concentration in Health and Biomedical Law)
2001-2004
Texas Tech University
BA
1987-1992
J. McDonald Skills
Biomedical Engineering
FDA
Design Control
Medical Devices
ISO 13485
CAPA
V&V
Regulatory Affairs
Technology Transfer
Biotechnology
Quality System
Validation
CE marking
GMP
Attorney
Standard Operating Procedure (SOP)
Change Control
Engineering
Quality Assurance
Regulatory Submissions
Medical Device R&D
FDA GMP
Leadership
Strategic Planning
Management
Microsoft Office
J. McDonald Summary
J. McDonald, based in Kirkland, WA, US, is currently a Vice President, RA and QA and Compliance Officer at FUJIFILM Sonosite, Inc.. J. McDonald brings experience from previous roles at Viant Medical, Focal, Inc. / Genzyme Corporation and Prucka Engineering, Inc. / GE Medical Systems. J. McDonald holds a 2001 - 2004 Juris Doctor in Certificate of Concentration in Health and Biomedical Law @ Suffolk University Law School. With a robust skill set that includes Biomedical Engineering, FDA, Design Control, Medical Devices, ISO 13485 and more. J. McDonald has 1 emails and 1 mobile phone numbers on RocketReach.
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