Baxter Healthcare - United States since Sep 2012
Associate Director, Global Regulatory Affairs - BioSurgery Franchise
Avery Dennison Medical - Greater Chicago Area Jul 2011 - Sep 2012
Regulatory Affairs
Deloitte & Touche LLC - Chicago, IL Jan 2011 - Apr 2011
Enterprise Risk Services - Medical Device and Healthcare Industry
Baxter Healthcare Corporation Dec 2004 - Dec 2010
Regulatory Affairs
BioLife Plasma Services Dec 2001 - Dec 2004
Regulatory Affairs
Education:
Augustana College 1994 - 1998
B.A., Biology, Medical Techonology, Cytotechnology
Jagiellonian University 1997 - 1997
Certificate, Native Speaker - Polish
Main East (Maine Township High School East) 1990 - 1994
Skills:
Regulatory Intelligence Retrieval Iso 14971 Corporate Functions Sales Identify Trends Advancement Regulatory Affairs Change Control Revisions Modernization U.s. Food and Drug Administration Herbal Federal Reporting Cross Functional Team Leadership Complaints Product Management Japan Regulatory Compliance Closure Management Science Organizational Leadership Quality Systems Regulatory Science Sop 21 Cfr Part 11 Metrics Product Distribution Spanish 21 Cfr Public Speaking Lean Manufacturing Workflow Human Resources Collaborative Seminars Gmp Guidance System Healthcare Validation Reports Strategy Medical Device Directive Strategies Revision Lifesciences V&V Piloting Training Supplements Customer Service News Plasma Physics Regulatory Submissions Subject Matter Expert Corrective and Preventive Action Documentation Project Management Product Development Quality Control Research Product Launch Investigation Capa Surveillance Revise Root Laboratory Design Control Harmonization Cross Functional Team Divisional Management Medical Technology Polish Pfmea Communication Standard Operating Procedure Life Sciences Account Creation European Union Quality Assurance Licensing Operations Stage Regulatory Requirements Quality System Service Quality Process Efficiency Project Contractual Agreements Facilities Management Dmaic Poland Encompassing Iso 13485 Six Sigma Regulations Distribution Numbering Intelligence Code Efficient Google Groups Biology Reimbursement State Laws Forms Regulatory Government Medical Devices Global Marketing Concurrent Compliance Product Lifecycle Management Quality Procedures Platforms Data Encryption Standard Kaizen Registrations Due Diligence Pharmaceutical Industry Marketing Strategy Supply Chain Eligibility Fda Commercialization
Interests:
Education Environment Science and Technology Human Rights Animal Welfare Arts and Culture Health