Founder / Instructor at Medical Device Academy, Consultant at Packard Consulting
Location:
Chester, Vermont
Industry:
Medical Devices
Work:
Medical Device Academy - Orlando, Florida Area since Jan 2013
Founder / Instructor
Packard Consulting - Chester, VT since Oct 2012
Consultant
Delcath Systems, Inc - Queensbury, NY Mar 2012 - Oct 2012
Sr. Manager, Regulatory Affairs
Packard Consulting - Chester, VT Feb 2008 - Mar 2012
External Resource for BSI & Consultant
Albright Technologies, Inc. - Leominster, MA Jul 2009 - Aug 2011
Director of QA/RA
Education:
The University of Connecticut 1989 - 1993
BS, Chemical Engineering
AAMI Course in DC
World Class Product Creation 2013 2013 - 2013
Skills:
510(k) Submissions CE Marking Canadian Medical Device Licensing Clinical Evaluation Reports Lead Auditor Management Experience (1-100+ People) Strategic Market Plans Fundraising for Start-ups Business Plan Writing Medical Devices Management CAPA Licensing Supplier Quality Electronic Submissions Business Planning Reports CE marking Lean Manufacturing Risk Management Auditing Sterilization Start-ups Market Planning Strategy Design Control ISO 13485 FDA Quality System PMA V&V Regulatory Affairs Regulatory Submissions Quality Assurance Continuous Improvement Quality Auditing R&D 21 CFR ISO 14971 Pharmaceutical Industry IVD ISO Validation Product Development GMP Manufacturing Change Control
Customer Service Microsoft Word Agriculture Research Microsoft Excel Powerpoint Agribusiness Business Planning Teaching Negotiation Event Planning Public Speaking Microsoft Office Strategic Planning Business Strategy Plant Nutrition Contract Farming Food Plant Protection Agricultural Production Precision Agriculture Soybean Market Research Seed Production Product Development Soil Fertility Marketing Strategy Equine Nutrition Potatoes Nutrient Management Sunflower Sheep Floriculture Pigs Wheat Insecticides Agricultural Marketing Beef Cattle Agricultural Chemicals