1997 -
2000 International Regulatory Affairs Manager @
Joseph Rac Education
Northeastern University
Joseph Rac Skills
510 K
Medical Devices
Life Sciences
PMA
EU
CE marking
FDA
GMP
Regulatory Submissions
Pharmaceutical Industry
IND
Validation
Clinical Development
Regulatory Affairs
Design Control
Quality Assurance
Lifesciences
European Union
CMC
Biopharmaceuticals
Biotechnology
Medical Device Directive
ISO 13485
GLP
Regulatory Requirements
Sop
CAPA
Clinical Trials
21 CFR Part 11
Oncology
Biologics
eCTD
V&V
Drug Development
NDA
CRO
Quality System
Technology Transfer
Change Control
GCP
FDA GMP
Regulations
Vaccines
ISO 14971
Aseptic Processing
GxP
Commercialization
Regulatory Documentation
Pharmacovigilance
Computer System Validation
Strategy
Computer System
Customer Service
Public Speaking
Business Strategy
Change Management
Joseph Rac Summary
Joseph Rac, based in Boston, MA, US, is currently a Regulatory Affairs Manager - International at CytoSorbents Inc.. Joseph Rac brings experience from previous roles at Sanofi, Allergan, Genzyme and BEAVER-VISITEC INTERNATIONAL, Inc.. Joseph Rac holds a Northeastern University. With a robust skill set that includes 510 K, Medical Devices, Life Sciences, PMA, EU and more. Joseph Rac has 2 emails on RocketReach.
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