Rob Packard Email & Phone Number
President and FDA 510k Consultant and Owner and Founder and Trainer @ Medical Device Academy, Inc.
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Rob Packard Location
- Shrewsbury, VT, US
Rob Packard Work
- now President and FDA 510k Consultant and Owner and Founder and Trainer @
- 2016 -now FDA 510k Consultant and Owner and Founder @
- 2012 -now QA and RA Subgroup Manager (11,000+ members) @ Medical Devices Group
- 2008 -2012 External Resource for BSI and Consultant @ Packard Consulting
- 2012 -2012 Sr. Manager, Regulatory Affairs @
- 2009 -2011 Director of QA and RA @ Albright Technologies, Inc.
- 2008 -2009 Director of Quality @
- 2007 -2008 Director of Quality @
- 2004 -2006 Director of QA and RA @
- 2003 -2004 CEO @ Micro-Invasive Technology, Inc.
- 2000 -2004 Consultant @ Smart Drug Systems, Inc.
- 2000 -2003 Owner, Managing Member @ Packard Labs, LLC
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 FDA eCopy, Medical Devices Group, 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 3 emails and 1 mobile phone numbers on RocketReach.
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