Adjunct Professor, School of Law @ (January 2015 - Present)
Director, Regulatory Affairs and Quality Assurance @ (May 2014 - July 2016)
Regulatory Affairs @ (July 2011 - September 2012)
Enterprise Risk Services - Medical Device and Healthcare Industry @ (January 2011 - April 2011)
Regulatory Affairs @ (December 2004 - December 2010)
Regulatory Affairs @ (December 2001 - December 2004)
Quality Assurance @ (July 1999 - December 2001)
Senior Manager @ Global Regulatory Affairs Operations
Manager, Global Regulatory Affairs Devices @
Manager @ Global Regulatory Affairs
Manager @
Associate, Quality Engineering @
Technician @
Jerzy Wojcik Education
Augustana College
B.A. ( Biology, Medical Techonology, Cytotechnology)
1994-1998
Jagiellonian University
Certificate ( Native Speaker - Polish)
1997-1997
Main East (Maine Township High School East) 1990-1994
Jerzy Wojcik Skills
Medical Devices
Regulatory Affairs
Quality System
FDA
ISO 13485
Quality Assurance
Regulatory Requirements
Strategy
Product Development
GMP
CAPA
Lifesciences
SOP
Regulatory Submissions
Cross-functional Team Leadership
ISO 14971
Change Control
Validation
21 CFR Part 11
Design Control
21 CFR
Product Launch
V&V
Quality Systems
Life Sciences
Marketing Strategy
Commercialization
Global Marketing
Pharmaceutical Industry
U.S. Food and Drug Administration (FDA)
Standard Operating Procedure (SOP)
Corrective and Preventive Action (CAPA)
Regulatory Intelligence
Retrieval
Corporate Functions
Sales
Identify Trends
Advancement
Revisions
Modernization
Herbal
Federal Reporting
Cross Functional Team Leadership
Complaints
Product Management
u.s. Food and Drug Administration Fda
Japan
Regulatory Compliance
Closure
Management
Standard Operating Procedure Sop
Science
Organizational Leadership
Regulatory Science
Metrics
Product Distribution
Spanish
Public Speaking
Lean Manufacturing
Workflow
Human Resources
Collaborative
Seminars
Guidance
System
Healthcare
Reports
Medical Device Directive
Strategies
Revision
Piloting
Training
Supplements
Customer Service
News
Plasma Physics
Subject Matter Expert
Documentation
Project Management
Quality Control
Research
Investigation
Surveillance
Revise
ROOT
Laboratory
Harmonization
Cross Functional Team
Divisional Management
Medical Technology
Polish
PFMEA
Communication
Account Creation
European Union
Licensing
Operations
Stage
Service Quality
Process Efficiency
Project
Contractual Agreements
Facilities Management
DMAIC
Poland
Encompassing
Six Sigma
Regulations
Distribution
Numbering
Intelligence
Code
Efficient
Google Groups
Biology
Reimbursement
State Laws
Forms
Regulatory
Government
Corrective and Preventive Action Capa
Concurrent
Compliance
Product Lifecycle Management
Quality Procedures
Platforms
Data Encryption Standard
Kaizen
Registrations
Due Diligence
Supply Chain
Eligibility
u.s. Food and Drug Administration
Corrective and Preventive Action
Standard Operating Procedure
Jerzy Wojcik Summary
Jerzy Wojcik, based in Chicago, IL, US, is currently a Senior Director, Regulatory Affairs and Quality Assurance at Edgeone Medical. Jerzy Wojcik brings experience from previous roles at Northwestern University, Edgeone Medical, Avery Dennison and Deloitte. Jerzy Wojcik holds a 1994 - 1998 B.A. in Biology, Medical Techonology, Cytotechnology @ Augustana College. With a robust skill set that includes Medical Devices, Regulatory Affairs, Quality System, FDA, ISO 13485 and more. Jerzy Wojcik has 3 emails and 1 mobile phone numbers on RocketReach.
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