Rob Packard
QA/RA Subgroup Manager (11,000+ members) at Medical Devices Group | Cuttingsville, Vermont, United States
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Rob Packard serves as the QA/RA Subgroup Manager at Medical Devices Group, a vibrant community of over 11,000 professionals dedicated to advancing the medical device industry. With a focus on quality assurance and regulatory affairs, Rob plays a pivotal role in guiding start-ups through the intricate landscape of medical device regulations. His expertise is particularly valuable in navigating the complexities of 510(k) submissions, CE Marking, and Canadian Licensing, making him an essential resource for emerging companies aiming to bring innovative medical solutions to market.
In his current role, Rob leads a dynamic team of professionals who are committed to building the best medical device quality and regulatory consulting firm for start-ups. The firm’s ten-person team operates entirely remotely, allowing for a flexible and collaborative work environment that fosters innovation and efficiency. Rob’s leadership in the QA/RA Subgroup, which boasts over 9,000 members, enables him to facilitate knowledge sharing and provide critical insights into best practices for regulatory submissions, quality auditing, and validation processes.
As a member of the newly formed Medical Device Advisory Board, Rob also contributes to a platform where industry experts provide invaluable guidance to medical device professionals. This initiative not only enhances the collective knowledge of the community but also empowers individuals to seek advice on critical topics ranging from clinical evaluation reports to quality systems and good manufacturing practices (GMP). Through his dedication and expertise, Rob Packard continues to shape the future of medical device quality and regulatory affairs, ensuring that start-ups have the support they need to succeed in a competitive marketplace.
QA/RA Subgroup Manager (11,000+ members) at Medical Devices Group in October 2012 to Present
FDA 510k Consultant / Owner / Founder at FDA eCopy in October 2016 to Present
President / FDA 510k Consultant / Owner / Founder / Trainer at Medical Device Academy, Inc. in October 2013 to Present
External Resource for BSI & Consultant at Packard Consulting in February 2008 to December 2012
Sr. Manager, Regulatory Affairs at Delcath Systems, Inc in March 2012 to October 2012
Director of QA/RA at Albright Technologies, Inc. in July 2009 to August 2011
Director of Quality at CAS Medical Systems in July 2008 to September 2009
Director of Quality at ConforMIS, Inc. in January 2007 to July 2008
Director of QA/RA at Z-Medica in April 2004 to December 2006
CEO at Micro-Invasive Technology, Inc. in April 2003 to March 2004
Consultant at Smart Drug Systems, Inc. in January 2000 to January 2004
Owner, Managing Member at Packard Labs, LLC in January 2000 to January 2003
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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
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
21 CFR Part 11
Technology Transfer
Commercialization
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What is Rob Packard email address?
Email Rob Packard at [email protected] and [email protected]. This email is the most updated Rob Packard email found in 2026.
What is Rob Packard phone number?
Rob Packard phone number is +18022581881 and +16266964357.
How to contact Rob Packard?
To contact Rob Packard send an email to [email protected] or [email protected]. If you want to call Rob Packard try calling on +18022581881 and +16266964357.
What company does Rob Packard work for?
Rob Packard works for Medical Devices Group
What is Rob Packard's role at Medical Devices Group?
Rob Packard is QA/RA Subgroup Manager (11,000+ members)
What industry does Rob Packard work in?
Rob Packard works in the Medical Equipment Manufacturing industry.
Rob Packard Email Addresses
Rob Packard Phone Numbers
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