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