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Rob Packard Location
Shrewsbury, VT, US
Rob Packard Work
President and FDA 510k Consultant and Owner and Founder and Trainer @ (October 2012 - Present)
QA and RA Subgroup Manager (11,000+ members) @ Medical Devices Group (October 2012 - Present)
FDA 510k Consultant and Owner and Founder @ (October 2016 - October 2023)
External Resource for BSI and Consultant @ Packard Consulting (February 2008 - December 2012)
Sr. Manager, Regulatory Affairs @ (March 2012 - October 2012)
Director of QA and RA @ Albright Technologies, Inc. (July 2009 - August 2011)
Director of Quality @ (July 2008 - September 2009)
Director of Quality @ (January 2007 - July 2008)
Director of QA and RA @ (April 2004 - December 2006)
CEO @ Micro-Invasive Technology, Inc. (April 2003 - March 2004)
Rob Packard Education
World Class Product Creation 2013 2013-2013
University of Connecticut
BS (Chemical Engineering)
1989-1993
Rob Packard Skills
FDA eSTAR
FDA PreSTAR
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
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
21 CFR Part 11
Technology Transfer
Commercialization
Consulting
Management Experience 1 100+ People
Start Ups
Regulatory
510k Submissions
Fundraising for Start Ups
Management Experience
510 Submissions
Rob Packard Summary
Rob Packard, based in Shrewsbury, VT, US, is currently a President and FDA 510k Consultant and Owner and Founder and Trainer at Medical Device Academy, Inc.. Rob Packard brings experience from previous roles at Medical Devices Group, FDA eCopy, Packard Consulting and Delcath Systems, Inc. Rob Packard holds a 2013 - 2013 World Class Product Creation 2013. With a robust skill set that includes FDA eSTAR, FDA PreSTAR, 510(k) Submissions, CE Marking, Canadian Medical Device Licensing and more. Rob Packard has 1 emails and 2 mobile phone numbers on RocketReach.
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