Fda Ecopy
Owner and Founder
Medical Device Academy
Founder and Instructor
Packard Consulting Feb 2008 - Dec 2012
External Resource For Bsi and Consultant
Delcath Systems, Inc Mar 2012 - Oct 2012
Senior Manager, Regulatory Affairs
Medical Devices Mar 2012 - Oct 2012
Qa and Ra Subgroup Manager
Education:
University of Connecticut 1989 - 1993
Bachelors, Bachelor of Science, Chemical Engineering
Skills:
Iso 13485 Medical Devices Fda Capa Quality System Design Control Quality Assurance Validation Regulatory Affairs Iso 14971 V&V Product Development Regulatory Submissions Ce Marking Iso Manufacturing Management Start Ups Quality Auditing Supplier Quality Strategy Gmp 21 Cfr Lean Manufacturing Technology Transfer R&D Continuous Improvement Auditing Risk Management 21 Cfr Part 11 Sterilization Pharmaceutical Industry Pma Commercialization Business Planning Licensing Market Planning Change Control Lead Auditor Electronic Submissions Canadian Medical Device Licensing Business Plan Writing Reports Ivd Management Experience Strategic Market Plans Fundraising For Start Ups 510 Submissions Clinical Evaluation Reports