2012 -2014 Head of Quality and Regulatory Affairs @
2009 -2011 Regulatory Affairs Manager @
1998 -2009 Various roles including R and D Manager, Supplier Quality, Supplier Auditor @
1995 -1998 Research Scientist @
1993 -1995 Development Scientist @ Unilever
Paula McCarthy Education
Munster Technological University
Master's degree (Clinical Biochemistry)
2002-2004
Dublin City University
Bachelor of Science (BSc) (Biotechnology)
1989-1993
Paula McCarthy Skills
ISO 14971
Change Control
21 CFR
Research
Biomedical Engineering
Regulatory Affairs
ISO 13485
Technical Files
Design Control
Biotechnology
FDA
u.s. Food and Drug Administration Fda
Product Development
Sop
Immunoassays
R&d
PMA
Product Launch
CAPA
Quality System
CE marking
Regulatory Submissions
Complaint Management
Life Sciences
Medical Devices
Lifesciences
Management
IVD
Public Relations
FDA GMP
GMP
Quality Assurance
Validation
Customer Service
Technology Transfer
Corrective and Preventive Action Capa
u.s. Food and Drug Administration
Corrective and Preventive Action
Paula McCarthy Summary
Paula McCarthy, based in Limerick, IE, is currently a Director Regulatory Affairs at Stryker. Paula McCarthy brings experience from previous roles at Stryker, Acorn Regulatory Consultancy Services Limited, TECHNOPATH and Beckman Coulter Biomedical. Paula McCarthy holds a 2002 - 2004 Master's degree in Clinical Biochemistry @ Munster Technological University. With a robust skill set that includes ISO 14971, Change Control, 21 CFR, Research, Biomedical Engineering and more. Paula McCarthy has 2 emails on RocketReach.
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